In vitro diagnostic kit related

In vitro diagnostic kit related, Total:92 items.

The international standard classification for "In vitro diagnostic kit related" includes: Laboratory medicine .

The Chinese standard classification for "In vitro diagnostic kit related" 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 1244-2014 Purified water for in vitro diagnostic reagents
YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents
YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
YY/T 1221-2013 Cardiac troponiniⅠ(cTnI ) diagnostic kit(Colloid gold method)

Professional Standard - Agriculture

179药典三部-2020 Monograph Ⅳ In Vitro Diagnostic HCV Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
135药典三部-2010 Each monograph catalog Ⅳ in vitro diagnostic human immunodeficiency virus antibody diagnostic kit (enzyme-linked immunoassay)
134药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis C virus antibody diagnostic kit (enzyme-linked immunoassay)
180药典三部-2020 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
162药典三部-2015 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum 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)
133药典三部-2010 Contents of each monograph ⅣIn vitro diagnosis of hepatitis B virus surface antigen diagnostic kit (enzyme-linked immunoassay)
181药典三部-2020 Monograph Ⅳ In Vitro Diagnostic Human Immunodeficiency Virus Antigen Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
161药典三部-2015 Monograph IV In Vitro Diagnostic Human Immunodeficiency Virus Antibody Diagnostic Kit (Enzyme-linked Immunoassay)
160药典三部-2015 Monograph Ⅳ In Vitro Diagnostic HCV 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)
111兽药典三部-2015 Text Contents Diagnostic Products Foot-and-Mouth Disease Type O Antibody Liquid Phase Blocking ELISA Detection Kit
183药典三部-2020 Monograph Ⅳ In Vitro Diagnosis Treponema pallidum Antibody Diagnostic Kit (Enzyme-linked Immunoassay)

Professional Standard - Hygiene

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

Swedish Institute for Standards

SS-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
SS-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
SS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Standards Norway

NS-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Ente Nazionale Italiano di Unificazione

UNI EN 13641:2003 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
UNI EN 376:2002 Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
UNI EN 376:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for self-testing.
UNI EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
UNI EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use.
UNI EN 13640:2002 Stability testing of in vitro diagnostic reagents

German Institute for Standardization

DIN EN 13641:2002-08 Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts
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.
DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
DIN EN ISO 23640:2013-09 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DIN EN ISO 23640:2012-03 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DIN EN ISO 23640 E:2013-04 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN EN ISO 23640 E:2013 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013

Gosstandart of Russia

GOST R EN 13641-2010 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
GOST R ISO 19001-2021 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for biological material staining
GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents
GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Spanish Association for Standardization (UNE)

AENOR UNE-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE-EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
AENOR UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13640:2002 Stability testing of in vitro diagnostic reagents.

Association Francaise de Normalisation

NF EN 13641:2002 Elimination or reduction of the risk of infection relating to in vitro diagnostic reagents
NF S92-041*NF EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
NF S92-011:1992 IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
NF S92-040:1999 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.

Bureau of Indian Standards

IS 17718-2022 Performance Testing Of In-Vitro Diagnostics Ivd Reagent Kit Alpha - Amylase Cnp-G3 Liquid Stable Clinical Chemistry Reagents/ Kits
IS/ISO 23640-2011 In Vitro Diagnostic Medical Devices —— Evaluation of Stability of in vitro Diagnostic Reagents

Korean Agency for Technology and Standards (KATS)

KS P ISO 23640-2019(2024) In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

British Standards Institution (BSI)

BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing of in vitro diagnostic reagents
BS EN 13640:2002 Stability testing of in vitro diagnostic reagents
BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN 376:1992 Specification for labelling of in vitro diagnostic reagents for self-testing
BS EN 375:1992 Specification for labelling of in vitro diagnostic reagents for professional use
BS EN ISO 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use

Danish Standards Foundation

DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
DS/EN 375:1993 In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
DS/EN 376:1993 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents

European Committee for Standardization (CEN)

EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN 376:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN 375:1992 In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents

Austrian Standards

ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use
ONORM EN 376-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing

International Organization for Standardization (ISO)

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

Belgian Standards Institute

NBN-EN 376-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing

Indonesia Standards

SNI ISO 23640:2018 In Vitro Diagnostic Medical Devices – Evaluation of the Stability of In Vitro Diagnostic Reagents (ISO 23640:2011, IDT)

Others: In Vitro Diagnostic Kit