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Chinese National Standard List: Medical laboratory equipment

Title Standard No. Implemented On
Performance validation of nucleic acid testing in blood screeningT/CAME 38-2021
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2）IgM antibody detection kitGB/T 40984-2021
Helicobacter pylori 14C-urea breath testT/CAME 36-2021
In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testingGB/T 19634-20212023-5-1
Diagnostic kit for colloidal gold immunochromatographic assayYY/T 1713-20202022-6-1
Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chipsGB/T 41407-20222022-4-15
Clinical laboratory testing and in vitro diagnostic test systems—Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseasesYY/T 1728-20212022-4-1
Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay)YY/T 1735-20212022-4-1
Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kitGB/T 40999-20212022-3-1
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kitGB/T 40966-20212022-3-1
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kitGB/T 40983-20212022-3-1
Medical refrigeratorYY/T 0086-20202022-1-1
Agar diffusion and dilution susceptibility test stripYY/T 1726-20202021-12-1
Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kitsYY/T 1709-20202021-12-1
Free thyroxine (FT4) testing kitYY/T 1721-20202021-12-1
Prealbumin testing kit (immune turbidity method)YY/T 1722-20202021-12-1
Alpha-fetoprotein testing kitYY/T 1216-20202021-6-1
Human gene single nucleotide polymorphisms (SNP) detection kitYY/T 1731-20202021-6-1
Free triiodothyronine (FT3)testing kitYY/T 1724-20202021-6-1
Fungus (1-3)-β-D-glucan testing kitYY/T 1729-20202021-6-1
Detection kit for morphine(colloidal gold method)YY/T 1656-20202021-3-1
PG Ⅰ/Ⅱ testing kitYY/T 1672-20192020-10-1
Insulin-like growth gactor Ⅰ testing kit YY/T 1674-20192020-10-1
Reference measurement procedure for determination of electrolytes(Potassium,sodium,calcium and magnesium)in serum (lon chromatography)YY/T 1675-20192020-10-1
Vitamin B12 testing kit ( labelling immunoassay ) YY/T 1677-20192020-10-1
Amphetamine detection kit ( colloidal gold method ) YY/T 1673-20192020-10-1
ABO reverse grouping reagents (Column agglutination technique,CAT)YY/T 1669-20192020-8-1
Parathyroid hormone testing kitYY/T 1664-20192020-8-1
Quality control material for clinical chemistry analyzerYY/T 1662-20192020-6-1
Follicle stimulating hormone testing kitYY/T 1213-20192020-6-1
Progesterone testing kitYY/T 1663-20192020-6-1
General technical requirements of quality control materials for in vitro diagnostic reagentsYY/T 1652-20192020-6-1
Automatic luminescence immunoassay analyzerYY/T 1155-20192020-6-1
Detection kit for IgG antibody to human parvovirus B19YY/T 1645-20192020-6-1
Medical carbon dioxide incubatorYY 1621-20182020-4-1
Medical biochemical incubatorYY/T 1641-20182020-1-1
Anti-TG quantitative labelling immunoassay kitYY/T 1594-20182019-5-1
Estradiol testing kit(Chemiluminescent immunoassay)YY/T 1589-20182019-5-1
Glycated albumin assay kit(enzymatic method)YY/T 1578-20182019-3-1
Heart-type fatty acid-binding protein testing kit (immune turbidity method)YY/T 1590-20182019-3-1
Folate testing kit (chemiluminescent immunoassay)YY/T 1583-20182019-3-1
Procalcitonin testing kitYY/T 1588-20182019-3-1
Individualized treatment tumor related gene mutation detection kit(Fluorescent PCR) YY/T 1586-20182019-3-1
Retinol binding protein testing kit(immune turbidity method)YY/T 1584-20182019-3-1
Colloidal gold immunochromatography readerYY/T 1582-20182019-3-1
Creatine kinase MB isoenzyme(CK-MB) testing kit (immunesuppression)YY/T 1580-20182019-3-1
Hemoglobin Alc testing kit(latex immunoturbidimetric method)YY/T 1605-20182019-3-1
In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagentsYY/T 1579-20182019-3-1
Allergy-specific IgE detection kitYY/T 1581-20182019-3-1
Influenza A virus nucleic acid detection kit(fluorescent PCR)YY/T 1596-20172018-12-1
Flow cytometerYY/T 0588-20172018-12-1
Total 25-hydroxyl vitamin D testing kit(labelling immunoassay)YY/T 1585-20172018-12-1
Detection kit for ketamine (Colloidal gold method)YY/T 1595-20172018-12-1
Detection kit for IgA antibody to epstein-barr viral capsid antigensYY/T 1517-20172018-4-1
ELISA analytical instrumentsYY/T 1529-20172018-4-1
Prolactin quantitative labelling immunoassay kitYY/T 1516-20172018-4-1
Calibrator for Biochemical AnalyzerYY/T 1549-20172018-4-1
Anti-herpes-simplex-virus IgM antibody detection reageant(kit)YY/T 1483-20162017-6-1
Anti-herpes-simplex-virus IgG antibody detection reageant(kit)YY/T 1482-20162017-6-1
Pregnancy-associated plasma protein A （PAPP-A） in serum test reagent （quantitative labelling immunoassay）YY/T 1422-20162017-6-1
Ischemia-modified albumin test reagentYY/T 1461-20162017-1-1
B-type natriuretic peptide and N-terminal pro—B-type natriuretic peptide test reagent(quantitative labelling immunoassay)YY/T 1451-20162017-1-1
Total protein test reagentYY/T 1444-20162017-1-1
Guidelines for values assignment of catalytic activity concentrations of enzymes using reference measurement procedures and evaluation of uncertaintyYY/T 1455-20162017-1-1
Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)YY/T 1458-20162017-1-1
Blood rheometerYY/T 1460-20162017-1-1
Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR)YY/T 1462-20162017-1-1
Dry hematology analyzer(centrifuge method)YY/T 1452-20162017-1-1
Apolipoproteia B test reagentYY/T 1421-20162017-1-1
Influenza A virus antigen detection kit(immunochromatographic assay)YY/T 1443-20162017-1-1
Apolipoprotein A-I test reagentYY/T 1450-20162017-1-1
Human ferritin quantitative test reagentYY/T 1456-20162017-1-1
Human gene in situ hybridization detection kitYY/T 1459-20162017-1-1
β2—Microglobulin quantitative detection reagents(kit)YY/T 1442-20162017-1-1
Chlamydia trachomatis DNA detection kit(fluorescent PCR)YY/T 1424-20162017-1-1
Electrolyte analyzerYY/T 0589-20162017-1-1
Lipoprotein(a) test reagentYY/T 1448-20162017-1-1
Diagnostic kit for IgG antibody to hepatitis E virus(ELISA)YY/T 1259-20152016-1-1
Total IgE quantitative labelling immunoassay kitYY/T 1252-20152016-1-1
High density lipoprotein(HDL)cholesterol assay kitYY/T 1254-20152016-1-1
Nucleic acid amplification reverse dot blot reagent(kit)YY/T 1303-20152016-1-1
Detection system of time-resolved fluoroimmunoassay―Part 2:Quantitative reagent(kit) for time-resolved fluoroimmunoassayYY/T 1304.2-20152016-1-1
Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)YY/T 1260-20152016-1-1
Detection system of time-resolved fluoroimmunoassay―Part 1:Semi-auto time-resolved fluoroimmunoassay analyserYY/T 1304.1-20152016-1-1
Neuron specific enolase quantitative labelling immunoassay kitYY/T 1262-20152016-1-1
Urine formed element analyzer(digital imaging automatic identification)YY/T 0996-20152016-1-1
Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kitYY/T 1257-20152016-1-1
Low density lipoprotein(LDL) cholesterol assay kitYY/T 1253-20152016-1-1
Ureaplasma nucleic acid amplification detection kitYY/T 1256-20152016-1-1
Immunoturbidimetry reagent (kit)YY/T 1255-20152016-1-1
Hepatitis B virus surface antibody(HBsAb) detection reagent(kit)(Chemiluminescent immunoassay)YY/T 1248-20142015-7-1
Purified water for in vitro diagnostic reagentsYY/T 1244-20142015-7-1
Pre-poured agar plateYY/T 1239-20142015-7-1
Cystatin C test reagent kitYY/T 1230-20142015-7-1
Cytomegalovirus(CMV)IgG/IgM antibody detection kitYY/T 1236-20142015-7-1
Diagnostic kit for IgG antibody to toxophasma(ELISA)YY/T 1237-20142015-7-1
Reagents for hematology analyzer―Part 3:DiluentYY/T 0456.3-20142015-7-1
L-Lactate dehydrogenase test reagent(kit)YY/T 1241-20142015-7-1
γ-Glutamyl transpeptadase test reagent kit(Method of GPNA)YY/T 1232-20142015-7-1
Detection kit for analysis of related chromosome and gene abnormalities in bladder cancer(Fluorescent in situ hybridization)YY/T 1224-20142015-7-1
Totle T3 quantitative labelling immunoassay kitYY/T 1222-20142015-7-1
Reagents for hematology analyzer―Part 2:HemolysinYY/T 0456.2-20142015-7-1
Automatic blood grouping analyzerYY/T 1245-20142015-7-1
Reagents for hematology analyzer―Part 4:Nucleated red blood cell enumeration reagentsYY/T 0456.4-20142015-7-1
In vitro diagnostic reagent(kit)nomenclature for clinical chemistryYY/T 1227-20142015-7-1
Insulin quantitative labelling immunoassay kitYY/T 1250-20142015-7-1
D-Dimer reagent (kit)YY/T 1240-20142015-7-1
Cardiac troponin-I(cTnI)quantitative detection reagent(kit)(Chemiluminescent immunoassay)YY/T 1233-20142015-7-1
Alkaline phosphatase test reagent kit(Method of NPP-AMP)YY/T 1234-20142015-7-1
Glycohemoglobin analyzerYY/T 1246-20142015-7-1
Hepatitis B virus surface antigen(HBsAg)detection reagent(kit)(Chemiluminescent immunoassay)YY/T 1247-20142015-7-1
Creatinine test reagent kit(Method of sarcosine oxidase)YY/T 1231-20142015-7-1
Free prostate specific antigen quantitative labelling immunoassay kitYY/T 1249-20142015-7-1
Human papillomavirus nucleic acid(genotyping)detection kitYY/T 1226-20142015-7-1
Reagents for hematology analyzer―Part 1:RinseYY/T 0456.1-20142015-7-1
Rubella IgG/IgM antibody detection kitYY/T 1235-20142015-7-1
Albumin test reagent kitYY/T 1228-20142015-7-1
Diagnostic kit for detection of anti-mycoplasma pneumoniaeYY/T 1225-20142015-7-1
Totle T4 quantitative labelling immunoassay kitYY/T 1223-20142015-7-1
Creatine kinase test reagent(kit)YY/T 1243-20142015-7-1
Erythrocyte sedimentation rate analyzerYY/T 1251-20142015-7-1
Reagents for hematology analyzer―Part 5:Reticulocyte enumeration reagentsYY/T 0456.5-20142015-7-1
Calcium test reagent kitYY/T 1229-20142015-7-1
α-Hydroxybutyrate dehydrogenase test reagent(kit)YY/T 1242-20142015-7-1
RhD(IgM) blood grouping reagent(monoclonal antibody)YY/T 1238-20142015-7-1
Urea assay kit(Enzyme coupling kinetic method)YY/T 1201-20132014-10-1
Sodium assay kit(Enzymic method)YY/T 1203-20132014-10-1
MacConkey sorbitol agar mediumYY/T 1210-20132014-10-1
Follicle stimulating hormone quantitative labelling immunoassay kitYY/T 1213-20132014-10-1
Gentamycin agar base mediumYY/T 1212-20132014-10-1
Aspartate aminotransferase diagnostic kit(IFCC method)YY/T 1198-20132014-10-1
Alpha-fetoprotein quantitative labelling immunoassay kitYY/T 1216-20132014-10-1
Luteinizing hormone quantitative labelling immunoassay kitYY/T 1217-20132014-10-1
Total bilirubin test kit (Vanadate oxidation method)YY/T 1205-20132014-10-1
Hepatitis C antibody diagnostic kit(Colloid gold method)YY/T 1215-20132014-10-1
Trypticase soy broth mediumYY/T 1219-20132014-10-1
BCYE agar mediumYY/T 1209-20132014-10-1
Thiosulfate-citrate-bile salts-sucrose agar mediumYY/T 1208-20132014-10-1
Uric acid assay kit (Uricase-PAP method)YY/T 1207-20132014-10-1
(Creatine kinase isoenzyme MB)(CK-MB) diagnostic kit(Colloid gold method)YY/T 1220-20132014-10-1
Alanine aminotransferase diagnostic kit (IFCC method)YY/T 1197-20132014-10-1
Thyroid-stimulating hormone quantitative labelling immunoassay kitYY/T 1218-20132014-10-1
Total cholesterol kit(COD-PAP method)YY/T 1206-20132014-10-1
Triglycerides assay kit(Oxidase method)YY/T 1199-20132014-10-1
Mannitol salt agar mediumYY/T 1211-20132014-10-1
Chloride assay kit(Enzymic method)YY/T 1196-20132014-10-1
Cardiac troponiniⅠ(cTnI ) diagnostic kit(Colloid gold method)YY/T 1221-20132014-10-1
Human chorionic gonadotrophin quantitative labelling immunoassay kitYY/T 1214-20132014-10-1
Total bile acids assay kit(Enzyme cycle method)YY/T 1204-20132014-10-1
Glucose assay kit(Enzymic method)YY/T 1200-20132014-10-1
Kalium assay kit(Enzymic method)YY/T 1202-20132014-10-1
Medical laboratories—Guidance on laboratory implementation of GB/T 22576—2008GB/Z 30154-20132014-8-1
In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftestingGB/T 29791.4-20132014-2-1
In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 5:In vitro diagnostic instruments for selftestingGB/T 29791.5-20132014-2-1
In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional useGB/T 29791.2-20132014-2-1
In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional useGB/T 29791.3-20132014-2-1
In vitro diagnostic medical devices―Information supplied by the manufacturer(labelling)―Part 1:Terms,definitions and general requirementsGB/T 29791.1-20132014-2-1
Dry chemistry urine analyzerYY/T 0475-20112013-6-1
reagent strips for urinalysisYY/T 0478-20112013-6-1
Human chorionic gonadotropin(HCG) quantitative detection reagent(kit)(chemiluminescent immunoassay)YY/T 1192-20112013-6-1
Lactose bile salt fermentation mediumYY/T 1190-20102012-6-1
Semi-automatic chemiluminescence immunoassay analyzerYY/T 1174-20102012-6-1
Detection reagent(kit) for enzyme-linked immunoabsorbent assay(ELISA)YY/T 1183-20102012-6-1
Monoclonal antibody reagent for flow cytometerYY/T 1184-20102012-6-1
Nutrient brothYY/T 1187-20102012-6-1
Carbohydrate antigen CA19-9 quantitative detection reagent(kit)—Chemiluminescent immunoassayYY/T 1178-20102012-6-1
Quantitative detection reagent(kit) for tumor markers—Chemiluminescent immunoassayYY/T 1175-20102012-6-1
Polymerase chain reaction analyzerYY/T 1173-20102012-6-1
Nucleic acids amplification test reagents(kits)YY/T 1182-20102012-6-1
China blue agar mediumYY/T 1189-20102012-6-1
EMB agar mediumYY/T 1188-20102012-6-1
Cancer antigen CA72-4 quantitative detection reagent(kit)—Chemiluminescent immunoassayYY/T 1177-20102012-6-1
Typing kit for human leucocyte antigen(HLA)—Sequence specific primer—SSPYY/T 1180-20102012-6-1
Cancer antigen CA15-3 quantitative detection reagent (kit)—Chemiluminescent immunoassayYY/T 1176-20102012-6-1
Medical laboratory quality management termYY/T 1172-20102012-6-1
Carbohydrate antigen CA50 quantitative detection reagent(kit)—Chemiluminescent immunoassayYY/T 1179-20102012-6-1
Immunohistochemistry kitYY/T 1181-20102012-6-1
Mueller hinton broth mediumYY/T 1186-20102012-6-1
In vitro diagnostic reagent(kit) for clinical chemistryGB/T 26124-20112011-11-1
Technical requirements for protective face mask for medical useGB 19083-20102011-8-1
Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapyYY/T 0690-20082010-1-1
Calibrator for hematology analyzerYY/T 0701-20082010-1-1
Control material for hematology analyzerYY/T 0702-20082010-1-1
Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmentYY 0648-20082009-12-1
Hematology analyzerYY/T 0653-20082009-6-1
Automated coagulation analyzerYY/T 0659-20082009-6-1
Automated blood culture systemYY/T 0656-20082009-6-1
Dry chemistry analyzerYY/T 0655-20082009-6-1
Agar MediumYY/T 0665-20082009-6-1
Semi-automated coagulation analyzerYY/T 0658-20082009-6-1
Medical centrifugeYY/T 0657-20082009-6-1
Automatic chemistry analyzerYY/T 0654-20082009-6-1
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materialsGB/T 21415-20082008-9-1
Guidelines on preparation and production of culture media - Part 2 : Practical guidelines on performance testing of culture mediaSN/T 1538.2-20072007-10-16
Salmonella-Shigella agar mediumYY/T 0578-20052006-12-1
Columbia Blood Agar Base MediumYY/T 0576-20052006-12-1
Electrolyte analyzerYY/T 0589-20052006-12-1
Semiautomatic biochemistry analyzerYY/T 0014-20052006-12-1
Fluid Thioglycollate MediumYY/T 0575-20052006-12-1
Nutrient Agar MediumYY/T 0577-20052006-12-1
Flow cytometerYY/T 0588-20052006-12-1
Biological safety cabinetsYY 0569-20052006-6-1
Rules for the inspection of medical equipment for import and export--Part 3: Transcranial Doppler blood flow analyzerSN/T 1672.3-20052006-5-1
Medical laboratories—Requirements for safetyGB 19781-20052005-12-1
Haemglobin instrumentYY/T 0032-20042005-11-1
Electrophoresis deviceYY/T 0087-20042005-11-1
Guidelines on preparation and production of culture media - Part 1 : General guidelines on quality assurance for the preparation of culture media in the laboratorySN/T 1538.1-20052005-7-1
GeneChip methods for identification of foodborne pathogensSN/T 1543-20052005-7-1
In vitro diagnostic test systems - General technical requirements for blood-glucose monitoring systems for self-testingGB/T 19634-20052005-5-1
General technical requirements for urine analyzerYY/T 0475-20042005-1-1
Regents for hematology analyzer use - Part 1: RinseYY/T 0456.1-20032004-1-1
Regents for hematology analyzer use - Part 2: HemolysinYY/T 0456.2-20032004-1-1
Regents for hematology analyzer use—Part 3:DiluentYY/T 0456.3-20032004-1-1
Luteinizing hormone(LH)test strip(Colloidal gold immunochromatographic assay)GB/T 18990-20082003-10-1
Electrophoresis chamberYY 0155-19941994-7-1
Micro oscillatorYY 0156-19941994-7-1
Disposable hemostixYY 0115-19931993-5-1
Electrophoresis InstrumentsYY 0087-19921992-10-1
Medical electrical equipment--Particular requirements for safety of haemodialysis equipmentGB 9706.2-19911992-4-1
Hard alloy insterted needle holdersYY 0032-19901991-6-1
Biochemical analyzerYY 0014-19901991-4-1
Electric heated constant temperature incubators YY 0027-19901991-4-1
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