In vitro diagnostic reagents

In vitro diagnostic reagents, Total:15 items.

The international standard classification for "In vitro diagnostic reagents" includes: Laboratory medicine , Diagnostic equipment .

The Chinese standard classification for "In vitro diagnostic reagents" includes: Medical laboratory equipment , Medical apparatus and devices in general , Sanitation in general .

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Professional Standard - Medicine

• YY/T 1244-2014 Purified water for in vitro diagnostic reagents
• YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry

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
• 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 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

国家发展和改革委员会

• WB/T 1116-2020 Mezzanine rack

国家药监局

• 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

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

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

SCC

• DIN EN 13640:2002 Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts
• DANSK DS/EN 13640:2002 Stability testing of in vitro diagnostic reagents
• NS-EN 13640:2002 Stability testing of in vitro diagnostic reagents

GOST

• GOST R EN 13640-2010 Stability testing of in vitro diagnostic reagents

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