Diagnostic reagents
Diagnostic reagents, Total:26 items.
The international standard classification for "Diagnostic reagents" includes: Laboratory medicine , Diagnostic equipment .
The Chinese standard classification for "Diagnostic reagents" includes: Medical laboratory equipment , Medical apparatus and devices in general , Sanitation in general .
Professional Standard - Medicine
- YY/T 1956-2025 Terms and definitions for clinical trials of in vitro diagnostic reagents
- YY/T 1244-2014 Purified water for in vitro diagnostic reagents
- YY/T 0639-2019 In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- YY/T 1709-2020 Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
- YY/T 1220-2013 (Creatine kinase isoenzyme MB)(CK-MB) diagnostic kit(Colloid gold method)
- 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)
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 29791.2-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use
- GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
- GB/T 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting
Group Standards of the People's Republic of China
- T/ZAS 2001-2020 Specification of unique identification code for in-vitro diagnostic reagent
Professional Standard - Goods and Materials
- WB/T 1116-2020 Mezzanine rack
Professional Standard - Hygiene
- WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline
Shanxi Provincial Standard of the People's Republic of China
- DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions
Professional Standard - Commodity Inspection
- SN/T 2435-2010 Protocol of quality assessment on the diagnostic kits used in entry-exit animal quarantine
Danish Standards Foundation
- DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents
German Institute for Standardization
- DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
Gosstandart of Russia
- GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents
Standards Norway
- NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents
Association Francaise de Normalisation
- NF S92-032:2002 Stability testing of in vitro diagnostic reagents.
Spanish Association for Standardization (UNE)
- UNE-EN 13640:2002 Stability testing of in vitro diagnostic reagents.
European Committee for Standardization (CEN)
- CEN EN 13640-2002 Stability Testing of in Vitro Diagnostic Reagents
British Standards Institution (BSI)
- BS EN 13640:2002 Stability testing 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
Ente Nazionale Italiano di Unificazione
- UNI EN 13640:2002 Stability testing of in vitro diagnostic reagents
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