GB/T 29791.2-2013 in English

VALID

In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use

Issued on:2013-10-10
Implemented on:2014-02-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $220.00
$214.00

Standard No:	GB/T 29791.2-2013
Document status:	VALID
Title in English:	In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use
Title in Chinese:	体外诊断医疗器械制造商提供的信息（标示）第2部分：专业用体外诊断试剂
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2013-10-10
Implemented on:	2014-02-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	GB-National Standard
Related Keywords:	vitro diagnostic medical devices vitro diagnostic instruments diagnostic reagents professional use scopethis part professional use
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《GB/T 29791.2-2013体外诊断医疗器械制造商提供的信息（标示）第2部分：专业用体外诊断试剂》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB/T29791的本部分规定了专业用体外诊断(IVD)试剂制造商提供信息的要求。
本部分也适用于预期与专业用体外诊断医疗器械一起使用的校准物、控制物质制造商提供的信息。
本部分也适用于IVD附件。
本部分适用于外包装和内包装标签以及使用说明。
本部分不适用于:
a) 体外诊断仪器或设备;
b) 自测用体外诊断试剂。

Scope

This part of GB/T 29791 specifies the requirements for information provided by manufacturers of in vitro diagnostic (IVD) reagents for professional use. This section also applies to information provided by manufacturers of calibrators and control substances intended to be used with professional in vitro diagnostic medical devices. This section also applies to IVD accessories. This section applies to outer and inner packaging labels and instructions for use. This section does not apply to: a) in vitro diagnostic instruments or equipment; b) in vitro diagnostic reagents for self-test.

More samples: JGJ 94-2008 GB 18306-2015 DL/T 368-2010

Sample only — not a preview of GB/T 29791.2-2013

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