YY/T 1232-2014: Gamma-Glutamyl transpeptadase test reagent kit (Method of GPNA)

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 1232-2014 (Self-service in 1-minute)
Newer / historical versions: YY/T 1232-2014

Preview True-PDF

Scope

This Standard specifies the technical requirements, test method, labeling, instructions for
use, packaging, transport and storage of γ-Glutamyl transpeptadase test reagent kit
(Method of GPNA).
This Standard applies to the γ-glutamyl transpeptadase test reagent (kit) that is used to
carry out quantitative determination of the γ-glutamyl transpeptadase activity in serum and
plasma, with the method of L-γ glutamyl-3-carboxyl-paranitroaniline. It includes manual
reagent and reagents used in semi-automatic and full-automatic biochemical analyzer.
This Standard does not apply to the dry γ-glutamyl transpeptadase test reagent (kit).
2  Normative References
The following document is indispensable for the application of this Document. For dated
references, only dated edition applies to this document. For undated references, the latest
edition (including all amendments) applies to this document.
GB 3100 The international system of units and its application
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
YY /T 0316 Medical devices - Application of risk management to medical devices
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
YY/T 0638 In Vitro Diagnostic Medical Devices. Measurement of Quantities in
Biological Samples. Metrological Traceability of Values Assigned to Enzymatic
Concentration of Calibrators and Control Materials

Basic Data

Standard ID	YY/T 1232-2014 (YY/T1232-2014)
Description (Translated English)	Gamma-Glutamyl transpeptadase test reagent kit (Method of GPNA)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	12,149
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB 3100; GB/T 21415; YY/T 0316; YY/T 0466.1; YY/T 0638
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to L-��- glutamyl-3-carboxy - p-nitroanilide substrate assay for serum or plasma ��- glutamyl transferase activity quantitative detection of ��- glutamyl transferase assay reagent (box), including manual reagents and on the semi-automat