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Immunology Five Items

Immunology Five Items, Total:154 items.

In the international standard classification, Immunology Five Items involves: Laboratory medicine, Protection against dangerous goods, Medical sciences and health care facilities in general, Microbiology, Farming and forestry, Veterinary medicine, Agricultural machines, implements and equipment, Raw materials for rubber and plastics, Milk and milk products, General methods of tests and analysis for food products, Quality, Vocabularies, Products of the textile industry, Applications of information technology, Protection against crime, Hospital equipment.

卫生健康委员会, Immunology Five Items

WS/T 654.1-2018 Reference intervals for commonly used clinical immunological test items Part 1: Serum immunoglobulin G, immunoglobulin A, immunoglobulin M, complement 3, complement 4
WS/T 645.1-2018 Reference intervals for commonly used clinical immunological test items Part 1: Serum immunoglobulin G, immunoglobulin A, immunoglobulin M, complement 3, complement 4
WS/T 645.2-2018 Part 2 of the reference intervals for commonly used clinical immunological test items: serum alpha-fetoprotein, carcinoembryonic antigen, sugar chain antigen 19-9, sugar chain antigen 15-3, sugar chain antigen 125

US-FCR, Immunology Five Items

FCR 21 CFR PART 866-2015 IMMUNOLOGY AND MICROBIOLOGY DEVICES
FCR 21 CFR PART 866-2014 IMMUNOLOGY AND MICROBIOLOGY DEVICES
FCR 21 CFR PART 866-2013 IMMUNOLOGY AND MICROBIOLOGY DEVICES

Professional Standard - Medicine, Immunology Five Items

YY/T 1181-2010 Immunohistochemistry kit
YY/T 1174-2010 Semi-automatic chemiluminescence immunoassay analyzer
YY/T 1817-2022
YY/T 1160-2009 Carcinoembryonic Antigen Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay)
YY/T 1162-2009 Alpha-fetoprotein quantitative detection reagent(Kit) (Chemiluminescent Immunoassay)
YY/T 1175-2010 Quantitative detection reagent (kit) for tumor markers.Chemiluminescent immunoassay
YY/T 1177-2010 Cancer antigen CA72-4 quantitative detection reagent (kit).Chemiluminescent immunoassay
YY/T 1179-2010 Carbohydrate antigen CA50 quantitative detection reagent(kit).Chemiluminescent immunoassay
YY/T 1176-2010 Cancer antigen CA15-3 quantitative detection reagent (kit).Chemiluminescent immunoassay
YY/T 1178-2010 Carbohydrate antigen CA19-9 quantitative detection reagent(kit).Chemiluminescent immunoassay
YY/T 1233-2014 Cardiac troponin-I(cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
YY/T 1161-2009 Tumor Associated Antigen CA125 Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay)
YY/T 1248-2014 Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)
YY/T 1247-2014 Hepatitis B virus surface antigen (HBsAg) detection reagent(kit) (Chemiluminescent immunoassay)
YY/T 1193-2011 Folicle stimulating hormone(FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
YY/T 1192-2011 Human chorionic gonadotropin(HCG) quantitative detection reagent(kit) (chemilumiuescent immunoassay)
YY/T 1458-2016 Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
YY/T 1163-2009 Total Prostate Specific Antigen(t-PSA) Quantitative Detection Reagent(Kit) (Chemiluminescent Immunoassay)

国家药监局, Immunology Five Items

YY/T 1181-2021 Immunohistochemistry Kit
YY/T 1828-2021 Anti-Müllerian hormone assay kit (chemiluminescence immunoassay)
YY/T 1735-2021 Hepatitis C virus antibody detection reagent (box) (chemiluminescence immunoassay)
YY/T 0616.7-2020 Disposable medical gloves Part 7: Immunological determination of antigenic protein content

Professional Standard - Agriculture, Immunology Five Items

16 OIE陆生动物诊断试验和疫苗手册-2005 Swine Influenza B 2: ELISA
309药典三部-2020 Bioassay 3429 Immunochemistry
14 OIE陆生动物诊断试验和疫苗手册-2005 Chicken infectious laryngotracheitis 2. Item d in serological test: enzyme-linked immunosorbent assay
258药典四部-2020 3400 Bioassay 3429 Immunochemical method
12 OIE陆生动物诊断试验和疫苗手册-2005 Avian mycoplasma disease (Mycoplasma gallisepticum) 2. Serological test item c: enzyme-linked immunosorbent assay (ELISA)
8 OIE陆生动物诊断试验和疫苗手册-2005 Goat and Sheep Brucellosis Item B 2nd Serological Test Enzyme-Linked Immunosorbent Assay: Indirect ELISA Competitive ELISA
1284药典化学药和生物制品卷-2010 Chapter 18 Biological Products 1. Toxins, Antitoxins and Immune Serum
257药典三部-2010 Appendix Ⅹ XP Determination of Biological Activity of Fc Segment in Human Immunoglobulin
KJ 201903 Rapid detection of barbiturates in health food by colloidal gold immunochromatography
325药典三部-2020 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
水产品质量安全检验手册 5.2.2.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 2 Determination of Chloramphenicol Residue in Aquatic Products 2. Enzyme-linked Immunoassay
水产品质量安全检验手册 4.5.2.0-2005 Chapter 4 Testing of Toxic Substances in Aquatic Products Section 5 Determination of Histamine in Aquatic Products 2. Method 2 Enzyme-linked Immunoassay
277药典四部-2015 3500 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
272药典四部-2020 3500 Biological Activity-Potency Assay 3514 Human Immunoglobulin Fc Fragment Biological Activity Assay
SN/T 5326.5-2023 Guidelines for Validation of Professional Analytical Methods for Import and Export of Food and Cosmetics Part 5: Immunological Methods
水产品质量安全检验手册 5.12.2.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 12 Determination of Streptomycin Residue in Aquatic Products 2. ELISA
水产品质量安全检验手册 5.13.2.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 13 Determination of Tylosin Residues in Aquatic Products 2. ELISA
296药典三部-2015 Biological activity-potency assay 3514 Human immunoglobulin Fc fragment biological activity assay general rules 128
水产品质量安全检验手册 5.5.3.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 5 Determination of Oxytetracycline, Tetracycline and Chlortetracycline Residues in Aquatic Products 3. Determination of Tetracycline Residues--Enzyme-linked Immunoassay
水产品质量安全检验手册 5.2.3.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 2 Determination of Chloramphenicol Residues in Aquatic Products 3. Enzyme-Linked Immunosorbent Assay (ELISA)
水产品质量安全检验手册 5.1.2.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 1 Determination of Diethylstilbestrol Residue in Aquatic Products 2. Radioimmunoassay (SN 0672-1997)
水产品质量安全检验手册 5.1.1.0-2005 Chapter 5 Drug Residue Test in Aquatic Products Section 1 Determination of Diethylstilbestrol Residue in Aquatic Products 1. ELISA (SCT 3020-2004)
水产品质量安全检验手册 9.4.5.0-2005 Chapter 9 Inspection of Fishing Feed Section 4 Testing of Toxins in Fishing Feed 5. Testing of Ochratoxin in Fishing Feed - ELISA

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Immunology Five Items

GB/T 27817-2011 Chemicals.Test method of immunotoxicity
GB/T 14926.55-2001 Laboratory animal--Immunohistochemistry(IH)
GB/T 17999.6-2008 SPF chicken.Microbiological surveillance.Part 6:Enzyme-linked immunosorbent assay for SPF chicken
GB/T 17999.10-2008 SPF chicken.Microbiological surveillance.Part 10:Indirect immunofluorescent assay for SPF chicken
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices

Group Standards of the People's Republic of China, Immunology Five Items

T/LXLY 16-2023 Implementation Rules for the Free Influenza Vaccination Project for the Elderly
T/CNMIA 0034-2021 Third-party medical testing (immunization) laboratory
T/CAME 58-2023 Microfluidic chip for chemiluminescence immunoassay
T/CVMA 33-2020 Chemiluminescent Immunoassay Detection Method for Peste des Petits Ruminants Virus Antibody
T/CVMA 30-2020 Chemiluminescent Immunoassay Detection Method for Foot-and-Mouth Disease Virus Type A Antibody
T/CVMA 31-2020 Chemiluminescent Immunoassay Detection Method for Foot-and-Mouth Disease Virus Type O Antibody
T/ZNZ 161-2023 Rapid detection of pentachlorophenol sodium residue in aquatic products Colloidal gold immunochromatographic method
T/GDID 1076-2023 Tubular chemiluminescence immunoassay for detecting antibodies of foot and mouth disease viruses serotype O
T/CVMA 26-2020 Tube Chemiluminescent Immunoassay Detection Method for Foot-and-Mouth Disease Virus Type O and Type A Antibodies
T/CVMA 35-2020 Chemiluminescent Immunoassay Detection Method for Antibody of CSFV
T/SZSMDA 004-2022 Technical specifications for immunological testing of blood transfusion departments in Shenzhen medical institutions
T/GDMDMA 0001-2022 Interleukin 6 Detection kit (Chemiluminescent Immunoassay)
T/GDMDMA 0028-2023 Heparin-binding Protein Testing Kit (chemiluminescent immunoassay)
T/CVMA 32-2020 Chemiluminescence Immunoassay Detection Method for Avian Leukosis Virus Antigen
T/CVMA 34-2020 Chemiluminescent Immunoassay Detection Method for Porcine Pseudorabies Virus gB Antibody
T/GDMDMA 0027-2023 N-terminal Propeptide of Type Ⅲ Procollagen Testing Kit (chemiluminescent immunoassay)
T/GDMDMA 0002-2022 Lipoprotein-associated Phospholipase A2 Detection kit(Chemiluminescent Immunoassay)
T/JAASS 8-2020 Derermination of chlorpyrifos from fruits and vegetables for export by immunochromatographic electrochemical method
T/CVMA 36-2020 Porcine Reproductive and Respiratory Syndrome Virus Immunohistochemical Detection Method
T/JAASS 7-2020 Derermination of parathion residues by Immunoaffinity electrochemical method
T/GDID 1077-2023 Tubular chemiluminescence immunoassay for detecting antibodies of african swine fever virus P30
T/GDID 1075-2023 Tubular chemiluminescence immunoassay for detecting antibodies of pseudorabies virus gB glycoprotein
T/CVMA 29-2020 Chemiluminescence immunoassay detection method for porcine reproductive and respiratory syndrome virus antibody

German Institute for Standardization, Immunology Five Items

DIN 58968-20:1990 Immunology; serodiagnosis of immune diseases; indirect immunofluorescence test, special requirements for the detection of autoantibodies
DIN 58967-20:2003 Medical microbiology and immunology - Diagnostics of infectious diseases and diseases of the immune system in serology and molecular biology - Part 20: General method-specific requirements for immunofluorescence tests (IFT)
DIN 58959-12 Bb.1:1997 Quality management in medical microbiology - Part 12: Requirements for the use of control material for testing immunological reagent kits; control material for commonly used immune diagnostics
DIN 58967-30:1999 Diagnostics of infectious diseases and diseases of the immune systems in serological and molecularbiology - Part 30: ELISA (Enzyme-Linked-Immuno-Sorbent-Assay); terms, general method-specific requirements
DIN CEN/TS 15633-3:2012-10*DIN SPEC 10700-2:2012-10 Foodstuffs - Detection of food allergens by immunological methods - Part 3: Quantitative determination of hazelnut with an enzyme immunoassay using polyclonal antibodies and Lowry protein detection; German version CEN/TS 15633-3:2012
DIN EN 15633-1:2019 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations
DIN EN 15633-1:2009 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations; English version of DIN EN 15633-1:2009-04
DIN 58969-41:1994 Medical microbiology; serodiagnosis of infectious diseases; immunoblot (IB); part 41: special requirements for the detection of antibodies against Human Immunodeficiency Virus HIV-1 or HIV-2
DIN CEN/TS 15633-2:2013-06*DIN SPEC 10700-1:2013-06 Foodstuffs - Detection of food allergens by immunological methods - Part 2: Quantitative determination of hazelnut with an enzyme immunoassay using monoclonal antibodies and bicinchoninic acid-protein detection; German version CEN/TS 15633-2:2013
DIN 58967-10:1994 Serodiagnosis of infectious diseases and diseases of the immune system; part 10: concepts, general requirements
DIN CEN/TR 16338:2014-12*DIN SPEC 10538:2014-12 Foodstuffs - Detection of food allergens - Template for supplying information about immunological methods and molecular biological methods; German version CEN/TR 16338:2012
DIN EN ISO 19020:2017-09 Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs (ISO 19020:2017); German version EN ISO 19020:2017
DIN EN 15633-1:2019-12 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations; German version EN 15633-1:2019
DIN EN ISO 21572:2020-02 Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019); German version EN ISO 21572:2019
DIN 58959-12:1997 Quality management in medical microbiology - Part 12: Requirements for the use of control material for testing immunological reagent kits
DIN EN ISO 21572:2020 Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019)
DIN CEN/TS 15633-3:2012 Foodstuffs - Detection of food allergens by immunological methods - Part 3: Quantitative determination of hazelnut with an enzyme immunoassay using polyclonal antibodies and Lowry protein detection; German version CEN/TS 15633-3:2012

国家卫生计生委, Immunology Five Items

WS/T 494-2017 Analysis quality requirements for important routine items in clinical qualitative immunoassay testing

国家药品监督管理局, Immunology Five Items

YY/T 1583-2018 Folic acid assay kit (chemiluminescence immunoassay)

国家食品药品监督管理局, Immunology Five Items

YY/T 1589-2018 Estradiol Assay Kit (Chemiluminescence Immunoassay)

API - American Petroleum Institute, Immunology Five Items

API PUBL 33-31750-1986 IMMUNOTOXICOLOGY OF BENZOPYRENES IN FISHER 344 RATS - FINAL REPORT

Professional Standard - Commodity Inspection, Immunology Five Items

SN/T 0423-2010 Detection of rabbit haemorrhagic disease virus in exporting frozen rabbits.Immunology method
SN/T 3314-2012 Quarantine protocal for okadaic acid in export marine products by enzyme enhancement chemiluminescence immunoassay
SN/T 2497.25-2010 Test method of import and export dangerous chemicals-Part 25: Determination of humoral immune function
SN/T 2497.24-2010 Test method of import and export dangerous chemicals-Part 24: Vitro test of cell immunologic function

Hunan Provincial Standard of the People's Republic of China, Immunology Five Items

DB43/T 1897-2020 General technical requirements for reference light sources for chemiluminescence immunoassay analyzers

American Society for Testing and Materials (ASTM), Immunology Five Items

ASTM D8238-18 Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins
ASTM D8238-18(2023) Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins
ASTM D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
ASTM D6499-16 Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

British Standards Institution (BSI), Immunology Five Items

DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN 15633-1:2019 Foodstuffs. Detection of food allergens by immunological methods - General considerations
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 19020:2017 Microbiology of the food chain. Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs
BS EN ISO 21572:2019 Foodstuffs. Molecular biomarker analysis. Immunochemical methods for the detection and quantification of proteins

RU-GOST R, Immunology Five Items

GOST R 59507-2021 Milk and milk raw material. Determination of residual content of antibiotics and drugs by immunological methods
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

North Atlantic Treaty Organization Standards Agency, Immunology Five Items

STANAG 2242-2005 POLICY FOR THE CHEMOPROPHYLAXIS AND IMMUNOTHERAPY OF NATO PERSONNEL AGAINST BIOLOGICAL WARFARE AGENTS

Danish Standards Foundation, Immunology Five Items

DS/EN 15633-1:2009 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations
DS/CEN/TS 15633-3:2012 Foodstuffs - Detection of food allergens by immunological methods - Part 3: Quantitative determination of hazelnut with an enzyme immunoassay using polyclonal antibodies and Lowry protein detection
DS/CEN/TS 15633-2:2013 Foodstuffs - Detection of food allergens by immunological methods - Part 2: Quantitative determination of hazelnut with an enzyme immunoassay using monoclonal antibodies and bicinchoninic acid-protein detection
DS/CEN/TR 16338:2012 Foodstuffs - Detection of food allergens - Template for supplying information about immunological methods and molecular biological methods

Lithuanian Standards Office , Immunology Five Items

LST EN 15633-1-2009 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations

PL-PKN, Immunology Five Items

PN-EN 15633-1-2020-03 P Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations

AENOR, Immunology Five Items

UNE-EN 15633-1:2009 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations
UNE-CEN/TS 15633-3:2013 EX Foodstuffs - Detection of food allergens by immunological methods - Part 3: Quantitative determination of hazelnut with an enzyme immunoassay using polyclonal antibodies and Lowry protein detection
UNE-CEN/TR 16338:2012 IN Foodstuffs - Detection of food allergens - Template for supplying information about immunological methods and molecular biological methods

Association Francaise de Normalisation, Immunology Five Items

NF V03-051-1*NF EN 15633-1:2019 Foodstuffs - Detection of food allergens by immunological methods - Part 1 : general considerations
NF U47-020:2001 Méthodes d'analyse en santé animale - Guide de bonnes pratiques de traitement de l'échantillon soumis à des analyses immuno-sérologiques
NF EN ISO 21572:2019 Produits alimentaires - Analyse des biomarqueurs moléculaires - Méthodes immunochimiques pour la détection et la quantification des protéines
FD V03-031*FD CEN/TR 16338:2013 Foodstuffs - Detection of food allergens - Template for supplying information about immunological methods and molecular biology methods
XP U47-310:2013 Animal health analysis methods - Biological reagents control for the immunological techniques used in animal health
NF V08-755*NF EN ISO 19020:2017 Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs
NF EN ISO 19020:2017 Microbiologie de la chaîne alimentaire - Méthode horizontale de détection des entérotoxines staphylococciques par test immuno-enzymatique dans les aliments

CEN - European Committee for Standardization, Immunology Five Items

PREN 15633-1-2018 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations

Korean Agency for Technology and Standards (KATS), Immunology Five Items

KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices

国家市场监督管理总局、中国国家标准化管理委员会, Immunology Five Items

GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5: Requirements in the field of clinical immunology examination
GB/T 40175.3-2021 Textiles—Methods of biochemical analysis—Part 3: Organophosphorus pesticide (enzyme-linked immunosorbent assay)
GB/T 40175.2-2021 Textiles—Methods of biochemical analysis—Part 2: Pyrethroid pesticides (enzyme-linked immunosorbent assay)

European Committee for Standardization (CEN), Immunology Five Items

PD CEN/TR 16338:2012 Foodstuffs - Detection of food allergens - Template for supplying information about immunological methods and molecular biological methods
EN 15633-1:2009 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations
EN ISO 19020:2017 Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs
PD CEN/TS 15633-2:2013 Foodstuffs - Detection of food allergens by immunological methods - Part 2: Quantitative determination of hazelnut with an enzyme immunoassay using monoclonal antibodies and bicinchoninic acid-protein detection

US-CFR-file, Immunology Five Items

CFR 21-866.3336-2014 Food and Drugs. Part866:Immunology and microbiology devices. Section866.3336:John Cunningham Virus serological reagents.
CFR 7-245.15-2014 Agriculture. Part245:Determining eligibility for free and reduced price meals and free milk in schools. Section245.15:Program income other than grants.

ES-UNE, Immunology Five Items

UNE-CEN/TS 15633-2:2013 Foodstuffs - Detection of food allergens by immunological methods - Part 2: Quantitative determination of hazelnut with an enzyme immunoassay using monoclonal antibodies and bicinchoninic acid-protein detection (Endorsed by AENOR in June of 2013.)
UNE-EN 15633-1:2020 Foodstuffs - Detection of food allergens by immunological methods - Part 1: General considerations
UNE-EN ISO 19020:2018 Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs (ISO 19020:2017)
UNE-EN ISO 21572:2020 Foodstuffs - Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins (ISO 21572:2019)

International Organization for Standardization (ISO), Immunology Five Items

ISO/CD TS 5384:2023 Health informatics - Categorial Structure and Data Elements for the Identification and Exchange of Immunization Data
ISO 19020:2017 Microbiology of the food chain - Horizontal method for the immunoenzymatic detection of staphylococcal enterotoxins in foodstuffs

Professional Standard - Public Safety Standards, Immunology Five Items

GA/T 1666-2019 General Technical Requirements for Forensic Science Morphine Urine Test Kit (Colloidal Gold Immunochromatography)
GA/T 1668-2019 General Technical Requirements for Forensic Science Cocaine Urine Test Kit (Colloidal Gold Immunochromatography)

US-CLSI, Immunology Five Items

CLSI I/LA28-A2-2011 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline- Second Edition