Other diagnostic kits

Other diagnostic kits, Total:47 items.

The international standard classification for "Other diagnostic kits" includes: Laboratory medicine .

The Chinese standard classification for "Other diagnostic kits" includes: Medical laboratory equipment , Sanitation in general .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

Professional Standard - Medicine

YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
YY/T 1220-2013 (Creatine kinase isoenzyme MB)(CK-MB) diagnostic kit(Colloid gold method)
YY/T 1221-2013 Cardiac troponiniⅠ(cTnI ) diagnostic kit(Colloid gold method)

Professional Standard - Agriculture

133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
162药典三部-2015 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
183药典三部-2020 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
178药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
136药典三部-2010 Each monograph catalog Ⅳ in vitro diagnosis Treponema pallidum antibody diagnostic kit (enzyme-linked immunoassay)
121兽药典三部-2015 Text Contents Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit
105兽药产品说明书范本第三册-2013 Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit Instructions
181药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
179药典三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
159药典三部-2015 Monograph Ⅳ In Vitro Diagnostic Hepatitis B Virus Surface Antigen Kit (Enzyme-linked Immunoassay)
160药典三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
110兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Virus Asia Type 1 Antibody Liquid Phase Blocking ELISA Detection Kit
180药典三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
106兽药产品说明书范本第三册-2013 Diagnostic Products Bovine and Sheep Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit Instructions
111兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Type O Antibody Liquid Phase Blocking ELISA Detection Kit
119兽药产品说明书范本第三册-2013 Diagnostic Products Porcine Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit Instructions
135兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit
134兽药典三部-2015 Text Contents Diagnostic Products Porcine Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit
135药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic human immunodeficiency virus antibody diagnostic kit (enzyme-linked immunoassay)
122兽药典三部-2015 Text Contents Diagnostic Products Cattle and Sheep Foot-and-Mouth Disease Virus Nonstructural Protein Antibody ELISA Diagnostic Kit
134药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis C virus antibody diagnostic kit (enzyme-linked immunoassay)
118兽药产品说明书范本第三册-2013 Diagnostic Products Porcine Foot-and-Mouth Disease Virus VP1 Structural Protein Antibody ELISA Diagnostic Kit Instructions
161药典三部-2015 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)

中华人民共和国国家卫生和计划生育委员会

WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline

Professional Standard - Commodity Inspection

SN/T 2435-2010 Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine

RU-GOST R

GOST R 51352-1999 Kits of reagents for clinical laboratory diagnostics. Test methods
GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications

GOSTR

GOST R 58569-2019 Kit for the animal’s brucellosis diagnosis by method of immunodiffusion. Specifications

GOST

GOST R 70150-2022 PCR kits for the animal diseases diagnostics. General requirements and test methods
GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents

SCC

DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents
DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

German Institute for Standardization

DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.

European Committee for Standardization (CEN)

EN 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing

Korean Agency for Technology and Standards (KATS)

KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

HU-MSZT

MSZ KGST 2703-1980 Malta Fever Laboratory Diagnosis

KR-KS

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

ES-UNE

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

RO-ASRO

STAS 9982/2-1974 DIAGNOSTIC X-RAY APPARATUS CASSETES FOR FILMS Dimensions

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