The third batch was free of clinical trial medical device catalog release
To do a good job in medical equipment registration and management work, according to the "Medical Device Supervision and Management Regulations", "Medical Device Registration Management Measures" (State Food and Drug Administration Order No. 4), "in vitro diagnostic reagents registration management approach" (National Food and Drugs Supervision and Administration Bureau Decree No. 5), the State Food and Drug Administration has organized the third batch of "exempted from clinical trials of the second category of medical devices directory" "from the clinical trial of the third category of medical devices directory" and "In vitro diagnostic reagents free from clinical trials", is now released, since the date of implementation.
announce.
Annex: 1. The list of the second category of medical devices exempt from clinical trials
Serial number
product name
Classification code
product description
Head nail
6810
The product is usually made of the main body, base, O-ring, rubber cap assembly, in which only the main body in contact with the body. The main body should use GB 4234, ISO 5832-1, ASTM F899 standard stainless steel or ISO 5832-3, GB / T 13810 standard Ti6Al4V, Ti6Al4VELI titanium alloy material, the product used in conjunction with the skull fixator in the skull needs severe repair of the surgical process of the patient's head and neck fixed in a specific location. Non-implants, only in the use of surgery, short contact with the human body, immediately removed after surgery.
Spinal surgery tools
6810
Spinal surgery tools are usually made of bone chisel, bite clamp, scraper, exciter, bone file, planer, cutter, stripper, product contact with the human body should be used in line with YY / T 0294.1 or ASTM F899 standard Made of stainless steel. Spinal surgery tools are used to assist in the treatment of spinal fractures with internal fixation to assist in the restoration of fractures to reconstruct anatomical relationships and provide immediate stability.
Spinal endoscopic surgical instruments
6810
Products from the grasping pliers, pliers pliers, basket pliers, bite clamp, bendable grasping pliers, scissors, working casing, dilator, ring saw, ring saw handle, ring saw protective sleeve, stripper, , Surgical instrument limiter, bone file, guide wire, probe, drill bit, planer, grinding head, depth sounder and other components, not with active equipment in combination. Products should be consistent with YY / T 0294.1 or ASTM F899 standard Made of stainless steel. Spinal endoscopic surgical instruments for spine endoscopy and surgery.
Arthroscopic endoscopic surgical instruments
6810
Products can be drilled by the drill limiter, screwdriver, hook knife, hollow hole device, guide, drill bit, no eccentric femoral sight, conical screwdriver, preset screw screwdriver, guide pin, screw guide pin, screw opening device, Pedicle screwdriver, femoral head device, general purpose handle, semi-circular file, cartilage holding device, rear outer beam tibial sight, rear outer beam femur sounder, plate inserter, tissue holder, ligament Bone finder, ligament finder, tendon gauge, torque handle, tendon finishing plate, bone tendon bone holder, probe, curette, stripper, closed hole, wire tapping, awl, working sheath, guided exchange Rods, micro-hook, arthroscopic special suction pipe sets, drill drill guide, puncture sheath core, threading device, pusher, bone hammer, drill, wire attack knife, arthroscope scissors, Trousers, crochet, puncture needle, threading needle, threading device, thread cutting machine, threading device, Grasping pliers, trotters, bite clamp, bone file, rotator cuff thread, poke, beak clamp, micro-perforation device, micro-fracture cone, Etc., contact with human body parts made in accordance with YY / T 0294.1 or ASTM F899 standard stainless steel, not with active instruments used in. For the wrist, elbow, shoulder, knee, hip, Ankle arthroplasty.
Medical intervertebral foramen surgery
6810
The product consists of a dilator, a guide rod, a nucleus pulposus, a probe, a protective sleeve, a cutting perimeter, a nerve retractor, a handle, a hammer, a lever clamp, a rotatable universal cervical spine kit, Manufactured in accordance with YY / T 0294.1 or ASTM F899 standard stainless steel, not in combination with active instruments. For use in intervertebral disc surgery or during operation.
Surgical instruments for intervertebral discs
6810
The product is made up of a dilator, a working sleeve, a probe, a ring saw, an adapter, a catheter, a handle, a spine, a forceps, etc. The contact with the body is made of stainless steel material according to YY / T 0294.1 or ASTM F899 And intervertebral disc with, for spinal disease examination and treatment.
Infant skull orthopedic fixator
6810
The product is made of shell, filler / pad, fixture. The product is suitable for 3-18 months, with moderate or severe non-bone fusion oblique head deformity, including oblique head, flat head and boat-shaped baby Treatment, by applying moderate pressure to the skull protrusion area to improve the symmetry and shape of the baby skull, and for 3 to 18 months after orthopedic surgery but with moderate to severe deformity, including oblique head, flat head and The use of a boat-like baby.
Intervertebral disc resection knife
6810
The disc resection is made of a stainless steel material that complies with YY / T 0294.1 or ASTM F899. It is used to cut the fibrous ring of the outermost layer of the disc.
Ring drill
6810
Usually hollow structure. Generally used in accordance with YY / T 0294.1 or ASTM F899 standard stainless steel material used for spinal surgery for bone or bone removal.
Spinal surgery channel system
6810
Spinal surgery supporting surgical tools, generally by the expansion of the channel, step by step expansion of the sleeve, distraction channel and the core and the depth of the composition of the use of medical polymer materials made of sterile. For the establishment of spinal surgery channel The
Meniscus suture surgical instruments
6810
The product consists of meniscus needle, guide tube, meniscus file composed of the main body should be used in line with ASTM F899, ASTM A269, ASTM A564 standards made of stainless steel material.
Uterine manipulator
6812
This product is usually made of stainless steel and macromolecular materials rod-shaped device. Sterile provided. Changes in abdominal surgery for uterine position can also be used to control and enhance the uterus.
Disposable uterine curette
6813
Macromolecule plastic products, Sterile single use, consists of curettage rod and curette head for obstetrics and gynecology surgery, scraping the wall of uterus.
Ophthalmic surgery microscope
6822
The product is generally composed of optical systems, control systems, lighting systems, stent systems, does not include optional features or components, clinically used to provide ophthalmic surgery to enlarge and lighting.
Electronic endoscope image processor
6822
The product is generally composed of the host and accessories, accessories include power cord, interface cable, data keyboard, etc., and electronic endoscopes and displays with the use of electronic endoscopes collected images processed and transported to the display.
Endoscopic surgery planing device
6822
Products generally by the host, handle, planing cutter head, driven by the motor motor handle and the head for mechanical rotation, for endoscopic surgery for bone or soft tissue removal, grinding, etc. applicable or reference to industry standards YY / T 0955 "endoscopic surgical planing device."
Fiber bronchoscopy
6822
The flexible fiber endoscope is usually composed of an optical imaging system and an illumination system. The optical imaging system is composed of three parts: objective lens, image system and eyepiece.The illumination system is composed of multi-beam guided optical fiber, And the optical fiber surface is focused on the optical fiber surface, and each pixel (each light guide fiber) on the optical fiber surface array receives the light energy corresponding to the position image, respectively, and the light energy Transmission to the other end of the transmission fiber, all the pixels in the square side of the entire light energy recombination to form the focus of the objective lens, and then by the eyepiece or camera system for observation. For bronchial observation, camera, can not be used for high Frequency surgery.
Electric stretcher
6825
The product is usually composed of a bed (trolley panel, stretcher face), a support frame, an additional infusion stand, a guard rail, a directional wheel pedal, a caster, a brake, a hand mechanism, etc. for a bicycle or a double car. , Move the patient with.
Hot paste
6826
Hot paste is usually made of iron powder, wood flour, activated carbon, sodium chloride, water and non-woven bags and other suitable materials for the body surface of the local hot compress, the way the heat transfer to the affected area, used to promote Local blood circulation, auxiliary anti-inflammatory, swelling and pain.
Usually by the sampling center, processing center, waste and supply center, the system control center, camera microscope, controller, support software and other components; for clinical samples from the human body immunofluorescence chip, chemiluminescence or enzyme Experiments and analysis of immunological methods, including automated loading, addition of reagents, operations, results readings, and quantitative and / or qualitative analysis of the analyte in the sample.
Electric dialysis chair
6845
This product is usually composed of seat, backrest, footrest, sliding foot pedal, pillow, handrail, lockable casters, push handle, controller, etc. Electric adjustment. Used to adjust the position including the back pad, cushion, foot pad , To facilitate the patient in dialysis treatment to find the most suitable medical posture.
Ultrasound treatment tips
6855
Products and dental ultrasonic scaler supporting the use of the body material is usually stainless steel, titanium alloy and other materials for oral root canal therapy in the repair of medullary wall, remove the root canal mouth obstacles, etc. can handle and head Material, type, size, etc. are divided into several models and specifications. The product body material must meet the relevant national and industry standards, performance indicators to meet the following standards in the applicable part, such as: YY 91010 "dental rotating equipment with the size" , And the basic principles, scope of application, performance and composition of the same product has been listed. Exemption does not include the listed product materials, technology, design or mechanism of action, function and other different products.
Dental needle (non-metallic)
6855
Dental rotating equipment, one by the resin, polyether ether ketone (peek) and other materials made by the handle and the head of the working end, according to the handle and the head of the material, type, size, etc. divided into several models And specifications for the dental treatment of dental drilling. Product performance indicators using the following reference standard in the applicable part, such as: YY 0761.1 dental rotating instrument diamond car needle 1: size, requirements, marking, YY 0302.1 dental rotating device car Needles - Part 1: Steel and Carbide Needles, YY 0302.2 Dental Rotary Gears - Part 2: Needles for steel and carbide alloys.
Orthodontic support with drilling
6855
Dental rotation of a device, composed of the handle and the head of the working end of the body material is usually stainless steel, titanium and other suitable materials for implantation of orthodontic anchorage before drilling in the cortical bone to determine orthodontic anchorage The material of the product must be in accordance with the relevant national and industry standards, : YY 91064 "Dental Rotary Gear Steel and Carbide Dental Drilling Technical Conditions", YY 91010 "Dental Rotary Equipments", etc., and the basic principles, scope of application, performance and composition are the same as those already listed. And has been listed products, materials, technology, design or mechanism of action, function and other different products.
Correction of the holder
6863
The product is made of medical grade polyvinyl chloride material, polyethylene terephthalate (PET) or medical silicone, and is a non-customized product with standard size for orthodontic treatment in the later stage of orthodontic treatment.
Dental hydrofluoric acid etching agent
6863
Usually by the one-component or two-component liquid or gel. General is phosphoric acid, lactic acid, citric acid, hydrofluoric acid, oxalic acid, polyacrylic acid, dilute sulfuric acid, etc. Use of the corrosion of acid play a role. Treatment, the use of corrosion of the etching agent on the tooth, metal, ceramics and other surface treatment to remove the contaminated layer, rough surface, improve its surface properties.
Temporary crown bridge material
6863
The product is a two-component paste or powder liquid, or one-component paste, or a preform. The main components are polyacrylates, polyvinyl esters, polycarbonates, etc. For the production of dental temporary repair The product performance is based on the applicable parts of the following reference standards, eg, YY / T 0826 Dental temporary polymer-based crown-bridge material. Exemptions do not include differences with the listed product materials, technology, design or mechanism, function, etc. product.
Desensitizer
6863
The product is usually one-component or two-component liquid, paste, gel. The main components of fluoride, etc., used to alleviate the sensitivity of dentin caused by tooth allergy symptoms.
Dental cutting alloy
6863
Dental cutting metal materials, including cobalt-chromium alloy, precious metal alloys, etc. For the production of CAD / CAM process crowns, dental bridges and other dental prostheses, product body materials and performance indicators to meet the relevant national and industry standards, such as : GB 17168 "Applicable parts of metal materials for dental fixation and activity restoration." Exemptions do not include products for the manufacture of implants and accessories.
Fluorine protection agent
6863
This product can be used for fluoride dental caries and treatment of dentin allergy. Adhesive membrane through the attachment of dentinal tubules to treat tooth allergy. The main ingredients are ethanol, sodium fluoride, rosin resin, titanium dioxide and so on.
Veneer
6863
Veneer, inlay is a kind of custom fixed denture, including metal inlay, metal porcelain inlay, all-ceramic inlay, all-ceramic veneer; metal inlay with dental cast alloy and other suitable materials, Metal porcelain inlay with dental porcelain casting alloy and high temperature porcelain powder or low temperature porcelain powder and other suitable materials, all-ceramic inlay, all porcelain veneer with zirconia and other suitable materials for the teeth Missing fixed fix.
Elastic denture
6863
Elastic denture is a custom type of active denture, generally composed of artificial teeth, base care; active denture with flexible base material, multi-layer synthetic resin teeth made for the deletion of teeth, dentition temporary repair, The repair time is generally no more than 6 months.
The product is used for denture-oriented planting planning and dental diagnostics. Obtained 3D images of the teeth in a dental scanner (CT or DVT) by coated denture or non-boltable components. The main components are polydimethylsiloxane , Barium sulfate, silica, and the like.
Orthodontic adhesive
6863
Mainly by the resin, filler, solvent, etc. For oral treatment of orthodontic treatment.
Glass - ionomer cement for photo - curing orthodontic bonding
6863
Usually as a liquid or paste. As a temporary implantation of human materials, for orthodontic products, bonding, short-term bonding or temporary filling.
Uterine positioning handle
6866
The products are made up of handles, triggers, shafts and clip-on joints for the aiming of the uterus during laparoscopic surgery as well as for the positioning of the uterus, fallopian tubes and ovaries, and for the administration of dyes during the surgery requiring staining of the fallopian tube.
Sinus balloon catheter
6877
Usually consists of balloon catheter, guide catheter, guide wire / light guide wire, irrigation catheter and other components. This product is sterilized, disposable. Used in the diagnosis and treatment procedures, the expansion of the ostium and sinus cavity space Of the device; can also be used in the target sinus rinse, thus completing the treatment procedures and facilitate the diagnosis process.
2. A list of the third category of medical devices that are exempt from clinical trials
Serial number
product name
Classification code
product description
Ureter endoscopy
6822
Which is usually composed of optical imaging system and illumination system.The optical imaging system consists of objective lens, image system and eyepiece.The illumination system is composed of multi-beam guide fiber arranged by mixing, The light source transmits light and provides illumination for the endoscopic image.The imaging system consists of a plurality of guided optical fibers arranged in a regular manner. The observed object is transmitted through the objective lens to the eyepiece through the objective lens and enlarged by the eyepiece or the imaging system for observation. The tube is a medical stainless steel that can contain a working channel for compatibility with surgical instruments and aspiration. The product is inserted into the urethra and is inserted through the bladder into the ureter for imaging of the ureter, observation and diagnosis.
Constant temperature nucleic acid amplification analyzer
6840
The products are mainly composed of the detection system, the heating module, the temperature control system, the touch screen and the random software.It can be divided into several models according to the working principle, technical parameter, expected use, additional auxiliary function and so on; adopt the constant temperature based on fluorescence detection Nucleic acid amplification technology, with the use of supporting the use of test panels, qualitative detection of human samples in the target nucleic acid with or without amplification.
With titanium plate
6846
The titanium plate shall be made of Ti6Al4V and Ti6Al4VELI titanium alloy according to GB / T 13810 and ISO 5832-3. The suture material shall be made of high molecular material such as poly (terephthalic acid) Ethylenediamine, Polyethylene, Polyester material, suitable for fixation of ligaments and tendons or bone in orthopedic reconstruction.
Orthopedic screws
6846
The products are made of stainless steel according to GB 4234, ISO 5832-1 and stainless steel according to GB / T 13810, ISO 5832-2, ISO 5832-3, ISO 5832-11, Ti6Al4V, Ti6Al4VELI, Ti6Al7Nb titanium alloy (Not including 3D printing and other innovative technology to prepare products.) Products used alone, for the limb bone fixation.
Fill the stick
6846
The product is made of pure tantalum according to ISO 13782 (not including innovative products such as 3D printing). Products are used alone for use in limb bone filling.
Acetabular cup with plug
6846
The product is made of GB / T 13810, ISO 5832-3 Ti6Al4V titanium alloy and is used with the acetabular cup for the packing of the acetabular cup product hole.
Medullary plug
6846
The product is made of ultra high molecular weight polyethylene material according to GB / T 19701.2, ISO 5834-2. It is used for bone cement prosthesis implantation to prevent bone cement from overflowing into medullary confinement area. , The tibia and the humeral of the medullary cavity.
Planing power system
6854
Products generally by the host, handle, planing cutter head, driven by the motor motor handle and the head for mechanical rotation, for open surgery or endoscopic surgery on bone or soft tissue, such as the removal, grinding and other operations applicable or Refer to the industry standard YY / T 0955 "Endoscopic Surgical Equipment Planer".
Hydrophilic fiber dressings
6864
Mainly composed of sodium carboxymethyl cellulose or ethyl sulfonate cellulose Expected use is limited to the protection of wounds, absorption of exudate, to provide a wet wound environment Exemption does not include: (1) Indications can promote epithelialization, guidance Tissue regeneration, promote wound healing, reduce pain, antibacterial, hemostatic, dissolve necrotic tissue, reduce scarring, anti-adhesion and other effects of the product; (2) claimed to be used in vivo wounds, third degree burn, infected wounds, necrotic tissue more Wounds, wounds, patients with wound sepsis and the like; (3) products containing active ingredients such as pharmaceuticals / medicinal active ingredients, biologicals / bioactives, silver, disinfectants, etc .; (4) other new products , Such as the use of new materials, new technologies, new designs or products with new mechanisms of action and new functions.
Needle-free connector
6866
The product generally consists of interfaces, fittings and tubing (optional), is a non-punctured infusion connector for use with an indwelling catheter, through which blood can be transfused or withdrawn. Does not include products that have positive pressure properties, use new materials, active ingredients, new technologies, new designs or have new mechanisms of action, new features.
Connecting pipe
6866
Used to connect syringes and contrast catheters, inject contrast and / or saline for angiography or to connect individual instrument access and extension access during interventional procedures.
3 from the clinical trials of in vitro diagnostic reagents directory
Serial number
Product Category
Product category name
expected usage
Management category
001
Ⅱ-1 reagent for protein detection
Hemoglobin testing reagent
Used to detect the human body samples of hemoglobin content, clinically mainly used for a variety of anemia, blood loss and other auxiliary diagnosis.
II
002
II-1 Reagents for protein detection
Sugarized hemoglobin analysis eluent
And glycosylated hemoglobin analysis system supporting the use of the sample used to detect the content of glycosylated hemoglobin.
II
003
II-1 Reagents for protein detection
Total protein detection reagent
Used to detect the content of total protein in human samples, mainly used to assist in the evaluation of liver function.
II
004
II-1 Reagents for protein detection
Albumin detection reagent
Used to detect the content of albumin in human samples, mainly used to assist in the evaluation of liver function and nutritional assessment.
II
005
II-1 Reagents for protein detection
Prealbumin detection reagent
Used to detect the content of prealbumin in human samples, mainly used to reflect the degree of liver damage and nutritional assessment.
II
006
II-1 Reagents for protein detection
Glycosylated hemoglobin detection reagent
Used to detect the content of glycosylated hemoglobin in human samples, clinically mainly used for the diagnosis of diabetes and blood glucose monitoring.
II
007
II-1 Reagents for protein detection
Microalbumin detection reagent
Used to detect microalbumin content in human samples, clinically used mainly for the diagnosis of kidney disease.
II
008
II-1 Reagents for protein detection
Myoglobin detection reagent
Used to detect the body protein samples of myoglobin, clinically used mainly for the diagnosis of myocardial infarction.
II
009
II-1 Reagents for protein detection
Troponin I detection reagent
Used to detect the content of troponin I in human samples, clinically used mainly for the diagnosis of myocardial infarction.
II
010
II-1 Reagents for protein detection
Troponin T detection reagent
Used to detect the content of troponin T in human samples, and is mainly used for the diagnosis of myocardial infarction.
II
011
II-1 Reagents for protein detection
Cardiac fatty acid binding protein detection reagent
It is used to detect the content of cardiac fatty acid binding protein in human samples. It is mainly used for the diagnosis of acute myocardial infarction.
It is used to detect the content of B-type natriuretic peptide (BNP) in human samples. It is mainly used for the diagnosis of heart failure.
II
014
II-1 Reagents for protein detection
Ischemic modified albumin detection reagent
For the detection of human samples in the ischemic modified albumin content, mainly as one of myocardial ischemia markers.
II
015
II-1 Reagents for protein detection
C-reactive protein detection reagent
Used to detect the content of C-reactive protein in human samples, C-reactive protein is mainly used as a non-specific inflammatory index.
II
016
II-1 Reagents for protein detection
α1-acid glycoprotein detection reagent
Used to detect the content of α1-acid glycoprotein in human samples, mainly as a non-specific inflammatory index.
II
017
II-1 Reagents for protein detection
Serum amyloid A detection reagent
Used to detect serum amyloid A content, mainly as a non-specific inflammatory indicators.
II
018
II-1 Reagents for protein detection
Ⅲ collagen detection reagent
It is used to detect the content of type Ⅲ collagen in human body samples. It is mainly used for the diagnosis of hepatic fibrosis.
II
019
II-1 Reagents for protein detection
Ⅳ collagen detection reagent
For the detection of human samples of collagen type Ⅳ content, mainly for the clinical diagnosis of liver fibrosis.
II
020
II-1 Reagents for protein detection
Laminin detection reagent
Used to detect human mucus in the sample content, clinically used for the diagnosis of liver fibrosis.
II
021
Ⅱ-1 reagent for protein detection
Unsaturated iron binding reagent
Used to detect human samples of unsaturated iron binding.Clinically used mainly for anemia, liver dysfunction, and other diseases caused by iron metabolism ancillary diagnosis.
II
022
Ⅱ-1 reagent for protein detection
Haptoglobin detection reagent
For the detection of human samples haptoglobin (haptoglobin) content, clinically used mainly for the diagnosis of intravascular hemolytic disease.
II
023
Ⅱ-1 reagent for protein detection
Cerebrospinal fluid / urine total protein detection reagent
Used to detect the content of total protein in cerebrospinal fluid / urine samples, clinically used for the diagnosis of central nervous system / kidney disease.
II
024
Ⅱ-1 reagent for protein detection
Retinol binding protein detection reagent
Used to detect the content of retinol binding protein in human samples, clinically used mainly for the diagnosis of liver or tubular injury.
II
025
Ⅱ-1 reagent for protein detection
Transferrin detection reagent
Used to detect human body sample transferrin content, clinically used mainly for iron deficiency, liver and other diseases of the auxiliary diagnosis.
II
026
Ⅱ-1 reagent for protein detection
Glycated serum protein detection reagent
Used to detect human serum glycoprotein in the sample, the clinical mainly for the monitoring of blood glucose levels.
II
027
Ⅱ-1 reagent for protein detection
Glycosylated serum albumin detection reagent
Used to detect human serum glycated albumin content, mainly for the clinical monitoring of blood glucose levels.
II
028
Ⅱ-1 reagent for protein detection
Pepsinogen Ⅰ detection reagent
Used to detect human samples of pepsinogen I content, clinically used mainly for the evaluation of gastrinic gland cell function.
II
029
Ⅱ-1 reagent for protein detection
Pepsinogen II detection reagent
Used to detect the human body sample pepsinogen Ⅱ content, clinically used to evaluate the gastric mucosal lesions.
II
030
II-1 Reagents for protein detection
Anti-streptolysin O detection reagent
Used to detect the human body samples of anti-streptolysin O content, clinically used mainly for acute rheumatic fever diagnosis.
II
031
II-1 Reagents for protein detection
Calcitonin detection reagent
It is used to detect the content of calcitonin (CT) in human samples. It is mainly used for the diagnosis of parathyroid function.
II
032
II-1 Reagents for protein detection
Calcitonin detection reagent
It is used to detect the content of procalcitonin (PCT) in human samples and is mainly used for the diagnosis of bacterial infectious diseases.
II
033
II-1 Reagents for protein detection
Osteocalcin detection reagent
Used to detect the human body sample osteocalcin content, clinically mainly used for a variety of osteoporosis and bone injury after the early evaluation of bone synthesis.
II
034
II-1 Reagents for protein detection
Ferritin detection reagent
Used to detect the content of ferritin in human samples, clinically mainly used for iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia diagnosis.
II
035
II-1 Reagents for protein detection
α2-macroglobulin detection reagent
For the detection of human samples in the α2-macroglobulin content, clinically used mainly for liver and kidney disease diagnosis.
II
036
II-1 Reagents for protein detection
Immunoglobulin detection reagent
It is used to detect the content of immunoglobulin G / A / M in human samples. It is mainly used for the evaluation of immune function and the auxiliary diagnosis of immune diseases.
II
037
II-1 Reagents for protein detection
Immunoglobulin G subtype detection reagent
(Such as IgG1, IgG2, IgG3, IgG4) content, clinically used mainly for the evaluation of immune function and immune disease, the diagnosis of the immune.
II
038
II-1 Reagents for protein detection
Specific IgG antibody detection reagent
Used to detect specific IgG antibody levels in human samples for foods such as meat, fish, corn, seafood, vegetables, and the like.
II
039
II-1 Reagents for protein detection
Soluble transferrin receptor detection reagent
It is used to detect the soluble transferrin receptor (sTfR) in human samples and is mainly used for the diagnosis of iron deficiency anemia.
II
040
II-1 Reagents for protein detection
α1-microglobulin detection reagent
It is used to detect the content of α1-microglobulin in human samples and is mainly used for the diagnosis of renal tubular injury.
II
041
II-1 Reagents for protein detection
beta2-microglobulin detection reagent
Used to detect the content of β2-microglobulin in human samples, mainly used to monitor the proximal renal tubular function.
II
042
II-1 Reagents for protein detection
Cystatin C detection reagent
Used to detect the content of cystatin C in human samples, mainly as one of the indicators to reflect the glomerular filtration rate.
(NGAL), which is mainly used to assist in the diagnosis of renal dysfunction. It is used to detect neutrophil gelatinase-related lipid transport protein (NGAL) in human samples.
II
044
II-1 Reagents for protein detection
Pregnancy Related Plasma Protein A Test Reagents
(PAPP-A) in human samples was used to assess the risk of Down's syndrome in three months before pregnancy.
II
045
II-1 Reagents for protein detection
Detection of bacterial sialidase
Used to detect sialidase activity in vaginal discharge samples, clinically used for the diagnosis of bacterial vaginosis.
II
046
Ⅱ-1 reagent for protein detection
Occult blood test reagent
For the detection of hemoglobin in human samples, clinically used primarily for hemorrhagic lesions of the initial inspection.
II
047
Ⅱ-1 reagent for protein detection
Stool occult blood test reagent
Hemoglobin in human fecal samples for the detection of clinically used to assess gastrointestinal bleeding.
II
048
Ⅱ-1 reagent for protein detection
Insulin-like growth factor binding protein detection reagent
For the detection of human samples of insulin-like growth factor binding protein (I, III), clinically used mainly for the diagnosis of growth disorders and premature rupture of membranes.
II
049
Ⅱ-1 reagent for protein detection
Serum tissue inhibitor of metalloproteinase I test
Used to detect human tissue samples of serum tissue inhibitor of metalloproteinase I content, clinically used for the diagnosis of liver fibrosis.
II
050
Ⅱ-1 reagent for protein detection
Kappa light chain detection reagent
For the detection of human samples (such as serum and urine) kappa light chain, clinically used mainly for autoimmune diseases, infections, liver disease, kidney disease and other auxiliary diagnosis.
II
051
Ⅱ-1 reagent for protein detection
λ light chain detection reagent
For the detection of human samples (such as serum and urine) in the light chain, mainly clinically used for autoimmune diseases, infections, liver disease, kidney disease and other auxiliary diagnosis.
II
052
Ⅱ-2 reagents for the detection of carbohydrates
Glucose detection reagent
Used to detect the content of glucose in human samples, mainly used to reflect the clinical blood glucose levels.
II
053
Ⅱ-2 reagents for the detection of carbohydrates
Beta-hydroxybutyric acid detection reagent
For the detection of human β-hydroxybutyric acid (hydroxybutyrate) content, clinically used for the diagnosis of ketoacidosis.
II
054
Ⅱ-2 reagents for the detection of carbohydrates
Lactate detection reagent
For the detection of human samples of lactic acid content, clinically mainly used for the diagnosis of metabolic acidosis.
II
055
Ⅱ-2 reagents for the detection of carbohydrates
Pyruvate test reagent
For the detection of pyruvate in human samples, clinically used for the diagnosis of ketoacidosis.
II
056
Ⅱ-4 reagents for the detection of enzymes
Alanine aminotransferase detection reagent
For the detection of alanine aminotransferase activity in human samples, clinically used to assist in the evaluation of liver function.
II
057
Ⅱ-4 reagents for the detection of enzymes
Aspartate aminotransferase detection reagent
For the detection of human aspartate aminotransferase activity in clinical samples, mainly for viral hepatitis, obstructive jaundice, myocardial infarction diagnosis.
For the detection of human aspartate aminotransferase isoenzyme activity in clinical samples, mainly for toxic hepatitis, obstructive jaundice, myocardial infarction diagnosis.
II
059
Ⅱ-4 reagents for the detection of enzymes
Alkaline phosphatase detection reagent
For the detection of alkaline phosphatase activity in human samples, clinically used mainly for the diagnosis of hepatobiliary disease and bone disease.
II
060
Ⅱ-4 reagents for the detection of enzymes
Lactate dehydrogenase detection reagent
For the detection of human samples of lactate dehydrogenase activity, mainly used in clinical diagnosis of myocardial infarction, liver disease and other diseases.
II
061
Ⅱ-4 reagents for the detection of enzymes
Lactate dehydrogenase isoenzyme detection reagent
For the detection of human samples of lactate dehydrogenase isoenzyme activity, mainly used for clinical diagnosis of myocardial infarction, liver disease and other diseases.
II
062
Ⅱ-4 reagents for the detection of enzymes
γ-glutamyl transferase detection reagent
It is used to detect the activity of γ-glutamyltransferase in human samples. It is mainly used for the diagnosis of hepatobiliary diseases.
It is used to detect the activity of creatine kinase isoenzyme in human samples. It is mainly used for the diagnosis of myocardium infarction and myopathy.
II
066
II-4 Reagents for enzyme detection
α-amylase detection reagent
Used to detect the activity of α-amylase in human samples, clinically used mainly for the diagnosis of pancreatic diseases.
II
067
II-4 Reagents for enzyme detection
Cholinesterase detection reagent
It is used to detect the activity of cholinesterase in human samples. It is mainly used for the diagnosis of liver injury and organophosphorus poisoning.
II
068
II-4 Reagents for enzyme detection
Butyrylcholine lipase detection reagent
It is used to detect the activity of butyrylcholinesterase in human samples. It is mainly used for the diagnosis of organophosphate poisoning.
II
069
II-4 Reagents for enzyme detection
Adenosine deaminase detection reagent
Used to detect the activity of adenosine deaminase in human samples. It is mainly used to evaluate the differential diagnosis of liver injury and pleural effusion.
II
070
II-4 Reagents for enzyme detection
Lipase detection reagent
Used to detect the activity of lipase in human samples, mainly for clinical diagnosis of acute pancreatitis.
II
071
II-4 Reagents for enzyme detection
Monoamine oxidase detection reagent
It is used to detect the activity of monoamine oxidase in human samples. It is mainly used for the diagnosis of hepatic fibrosis.
II
072
II-4 Reagents for enzyme detection
5'-nucleotidase detection reagent
It is used to detect the activity of 5'-nucleotidase in human samples and is mainly used for the diagnosis of hepatobiliary diseases.
II
073
II-4 Reagents for enzyme detection
α-hydroxybutyrate dehydrogenase detection reagent
It is used to detect the activity of α-hydroxybutyrate dehydrogenase in human samples. It is mainly used for the diagnosis of myocardial infarction.
II
074
II-4 Reagents for enzyme detection
N-acetyl-β-D-glucosaminidase detection reagent
For the detection of human samples of N-acetyl-β-D-glucosaminidase activity, clinically used to assist in the evaluation of renal tubular damage.
II
075
II-4 Reagents for enzyme detection
Superoxide dismutase detection reagent
It is used to detect the activity of superoxide dismutase in human samples. It is mainly used to evaluate the antioxidant capacity of the body.
It is used to detect the activity of glycylated proline dipeptidyl aminopeptidase in human samples. It is mainly used for the diagnosis of hepatobiliary diseases and gastrointestinal diseases.
II
077
II-4 Reagents for enzyme detection
Glutathione reductase detection reagent
It is used to detect the activity of glutathione reductase in human samples and is mainly used for the diagnosis of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
II
078
II-4 Reagents for enzyme detection
α1-antitrypsin detection reagent
For the detection of α1-antitrypsin (α1-protease inhibitor) activity in human samples, mainly as one of non-specific inflammatory markers.
II
079
II-4 Reagents for enzyme detection
Leucine aminotransferase detection reagent
It is used to detect the activity of leucine aminotranspeptidase in human samples. It is mainly used for the diagnosis of liver and gallbladder diseases.
II
080
II-4 Reagents for enzyme detection
Aldolase detection reagent
Used to detect the activity of aldolase in human samples, mainly used in clinical diagnosis of liver and other diseases.
II
081
II-4 Reagents for enzyme detection
Renin test reagent
Used to detect the human body sample renin activity, clinically mainly used for renal hypertension, endocrine hypertension in the auxiliary diagnosis.
II
082
II-4 Reagents for enzyme detection
Angiotensin converting enzyme detection reagent
It is used to detect the activity of angiotensin converting enzyme in human samples. It is mainly used for the diagnosis of hypertension and the diagnosis of sarcoidosis.
II
083
II-4 Reagents for enzyme detection
Trypsin detection reagent
Used to detect the activity of trypsin in human samples, clinically used mainly for the diagnosis of pancreatic disease.
II
084
II-4 Reagents for enzyme detection
Isocitrate dehydrogenase detection reagent
It is used to detect the activity of isocitrate dehydrogenase in human samples. It is mainly used for the diagnosis of liver diseases.
II
085
II-4 Reagents for enzyme detection
Myeloperoxidase detection reagent
It is used to detect the activity of myeloperoxidase (MPO) in human samples and is clinically used clinically primarily for the diagnosis of cardiovascular system inflammation.
II
086
II-5 Reagents for ester detection
Cholesterol detection reagent
Used to detect the content of cholesterol in human samples, clinically used mainly for the diagnosis of hypercholesterolemia.
II
087
Ⅱ-5 for the detection of esters reagents
Free cholesterol test reagent
For the detection of free cholesterol in human samples, clinically used for the diagnosis of liver disease.
II
088
Ⅱ-5 for the detection of esters reagents
Triglyceride detection reagent
Used to detect the content of triglycerides in human samples, clinically used mainly for the diagnosis of hypertriglyceridemia.
II
089
Ⅱ-5 for the detection of esters reagents
Free fatty acid detection reagent
Used to detect the content of free fatty acids in human samples, clinically used mainly for the diagnosis of hyperlipidemia, coronary heart disease and atherosclerosis.
For the detection of human samples of high-density lipoprotein cholesterol content, clinically used mainly for the diagnosis of hypercholesterolemia, coronary heart disease and atherosclerosis.
For the detection of human samples of low-density lipoprotein cholesterol content, clinically used mainly for the diagnosis of hypercholesterolemia, coronary heart disease and atherosclerosis.
II
092
Ⅱ-5 for the detection of esters reagents
Lipoprotein a detection reagent
Used to detect the content of human apolipoprotein a, the clinical mainly used to evaluate the risk of cardiovascular disease.
II
093
Ⅱ-5 for the detection of esters reagents
Apolipoprotein A1 detection reagent
Used to detect human samples of apolipoprotein A1 content, mainly used to evaluate the clinical risk of cardiovascular disease.
II
094
Ⅱ-5 for the detection of esters reagents
Apolipoprotein A2 detection reagent
Used to detect human samples of apolipoprotein A2 content, the clinical mainly used to evaluate the risk of cardiovascular disease.
II
095
Ⅱ-5 for the detection of esters reagents
Apolipoprotein B detection reagent
Used to detect the content of apolipoprotein B in human samples, clinically used to assess the risk of cardiovascular disease.
II
096
II-5 Reagents for ester detection
Apolipoprotein C2 detection reagent
Used to detect the content of apolipoprotein C2 in human samples, clinically used to assess the risk of cardiovascular disease.
II
097
II-5 Reagents for ester detection
Apolipoprotein C3 detection reagent
Used to detect the content of apolipoprotein C3 in human samples, clinically used to assess the risk of cardiovascular disease.
II
098
II-5 Reagents for ester detection
Apolipoprotein E detection reagent
Used to detect the content of apolipoprotein E in human samples, clinically used to assess the risk of cardiovascular disease.
II
099
II-7 Reagents for Inorganic Ion Detection
Iodine detection reagent
Used to detect the content of iodine in human samples, clinically used mainly for thyroid disease diagnosis.
II
100
II-7 Reagents for Inorganic Ion Detection
Ammonia detection reagents
Used to detect the content of ammonia in the human sample, clinically used mainly for the diagnosis of hepatic encephalopathy.
II
101
II-7 Reagents for Inorganic Ion Detection
Chlorine detection reagent
Used to detect the content of chlorine in human samples, clinically used mainly for hyperbrichlorosis or hypochloride secondary diagnosis.
II
102
II-7 Reagents for Inorganic Ion Detection
Carbon dioxide detection reagent
Used to detect the body of carbon dioxide in the sample content, clinically, as the body of acid and alkali balance of the evaluation index.
II
103
II-7 Reagents for Inorganic Ion Detection
Mercury detection reagents
Used to detect mercury content in human samples, clinically used mainly for the diagnosis of mercury poisoning.
II
104
II-7 Reagents for Inorganic Ion Detection
Lithium detection reagent
Used to detect the content of lithium in human samples, clinically used mainly for the diagnosis of lithium salt poisoning.
II
105
II-7 Reagents for Inorganic Ion Detection
Calcium test reagents
Used to detect the content of calcium in human samples, clinically used mainly for the diagnosis of calcium metabolism disorders.
II
106
II-7 Reagents for Inorganic Ion Detection
Copper detection reagent
Used to detect the content of copper ions in human samples, mainly used for clinical diagnosis of copper metabolism disorders.
II
107
II-7 Reagents for Inorganic Ion Detection
Potassium detection reagent
Used to detect the content of potassium in human samples, clinically used mainly for the diagnosis of potassium metabolism disorders.
II
108
II-7 Reagents for Inorganic Ion Detection
Magnesium detection reagent
Used to detect the content of magnesium ions in human samples, mainly used for clinical diagnosis of magnesium metabolism disorders.
II
109
II-7 Reagents for Inorganic Ion Detection
Sodium detection reagent
Used to detect the content of sodium ions in human samples, clinically used mainly for the diagnosis of sodium metabolic disorders.
II
110
II-7 Reagents for Inorganic Ion Detection
Phosphorus detection reagent
Used to detect the content of phosphorus in human samples, mainly used for clinical diagnosis of phosphorus metabolism disorders.
II
111
II-7 Reagents for Inorganic Ion Detection
Zinc detection reagent
Used to detect the content of zinc ions in human samples, clinically mainly used for auxiliary diagnosis of zinc metabolism disorders.
II
112
II-7 Reagents for Inorganic Ion Detection
Iron detection reagents
Used to detect the content of iron ions in human samples, clinically used mainly for the diagnosis of anemia.
II
113
II-7 Reagents for Inorganic Ion Detection
Total iron binding force detection reagent
Used to detect the total body of the human body binding force, clinically used mainly for the diagnosis of anemia.
II
114
II-11 for other physiological, biochemical or immune function test reagents
Creatinine detection reagent
Used to detect the content of creatinine in human samples, which is mainly used as one of the evaluation indexes of renal function.
II
115
II-11 for other physiological, biochemical or immune function test reagents
Uric acid detection reagent
Used to detect the content of uric acid in human samples, clinically used mainly for the diagnosis of hyperuricemia.
II
116
II-11 for other physiological, biochemical or immune function test reagents
Urea detection reagent
The product is used to quantitatively determine the content of urea in human samples, which is mainly used as one of the evaluation indexes of renal function.
