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GB/T 26124-2011 in English

GB/T 26124-2011 in English

VALID

In vitro diagnostic reagent(kit) for clinical chemistry

  • Issued on:2011-05-12
  • Implemented on:2011-11-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $280.00
$272.00
Standard No: GB/T 26124-2011
Document status: VALID
Title in English: In vitro diagnostic reagent(kit) for clinical chemistry
Title in Chinese: 临床化学体外诊断试剂(盒)
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2011-05-12
Implemented on: 2011-11-01
ICS Classification: 11.100-Laboratory medicine
Chinese Classification: C44-Medical laboratory equipment
Professional Classification: GB-National Standard
Related Keywords: vitro diagnostic reagents
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《GB/T 26124-2011临床化学体外诊断试剂(盒)》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。


Scope

This standard specifies the general technical requirements for the quality inspection of clinical chemical in vitro diagnostic reagents (boxes) (hereinafter referred to as "reagents (boxes)"), including terms and definitions, classification and naming, requirements, test methods, labels and instructions for use, packaging, Transport and storage. This standard applies to in vitro diagnostic reagents (boxes) based on the principle of spectrophotometry used in medical laboratories for quantitative testing of clinical chemistry items. This standard does not apply to: a) Performance evaluation reagents (such as reagents for research use only); b) POCT (point-of-care rapid test) clinical chemical in vitro diagnostic reagents.

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