GB/T 26124-2011 in English
VALIDIn 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
$272.00
《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.

Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.
We also recommend
-

GB/T 18990-2008 in English
Luteinizing hormone(LH)test strip(Colloidal gold immunochromatographic assay)
2003-03-05 -

GB/T 29791.1-2013 in English
In vitro diagnostic medical devices―Information supplied by the manufacturer(labelling)―Part 1:Terms,definitions and general requirements
2013-10-10 -

GB/T 40672-2021 in English
Clinical laboratory testing—Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
2021-10-11