GB/T 26124-2011: In Vitro Diagnostic Reagent (kit) for Clinical Chemistry

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Scope

This Standard specifies the general technical requirements for the quality inspection
of in vitro diagnostic reagent (kit) for clinical chemistry [hereinafter referred to as
“reagent (kit)”], including terms and definitions, classification and naming,
requirements, test methods, labels and instructions for use, packaging, transportation
and storage.
This Standard is applicable to in vitro diagnostic reagents (kits) based on the principle
of spectrophotometry used in the quantitative inspection of clinical chemistry items in
medical laboratories.
This Standard does not apply to.
a) Performance evaluation reagents (for example, reagents for research
purposes only);
b) In vitro diagnostic reagents for clinical chemistry in POCT (Point of Care
Testing).

Basic Data

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	17,189
Date of Issue	2011-05-12
Date of Implementation	2011-11-01
Quoted Standard	GB 3100; YY 0466-2003; YY/T 0638
Regulation (derived from)	Announcement of Newly Approved National Standards No. 6 of 2011
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic 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.