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GB/T 26124-2011 (GBT 26124-2011)

Chinese standards (related to): 'GB/T 26124-2011'
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GB/T 26124-2011English285 Add to Cart 0--10 minutes. Auto immediate delivery. In vitro diagnostic reagent (kit) for clinical chemistry GB/T 26124-2011 Valid GBT 26124-2011

Standard ID GB/T 26124-2011 (GB/T26124-2011)
Description (Translated English) In vitro diagnostic reagent (kit) for clinical chemistry
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 17,119
Date of Issue 2011-05-12
Date of Implementation 2011-11-01
Quoted Standard GB 3100; YY 0466-2003; YY/T 0638
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Medical clinical testing laboratories and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) Announcement of Newly Approved National Standards No. 6 of 2011
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This standard specifies the clinical chemistry in vitro diagnostic reagents (Box) (hereinafter referred to as "reagent (box) ") quality inspection of general technical requirements, including terms and definitions, classification and naming requirements, test methods, labeling and instructions for use, packaging, transport and storage. This standard applies to medical laboratory tests for clinical chemistry project uses quantitative spectrophotometric principle based on in vitro diagnostic reagents (box). This standard does not apply to: a) performance evaluation reagents (eg for research use only reagents), b) POCT bedside rapid detection) Clinical Chemistry in vitro diagnostic reagents.