DZ/T 0101.12-1994
Active
YY/T 1883-2023
Active
Industry standards-Medicine
YY/T 1883-2023 Rh blood system C、c、E、e blood grouping reagents(Column agglutination technique,CAT)
YY/T 1883-2023 Rh blood system C、c、E、e blood grouping reagents(Column agglutination technique,CAT)
Basic Information
Standard Code:
YY/T 1883-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2023-03-14
Implement Date:
2024-05-01
Publisher:
国家药品监督管理局
Technical Committee:
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(SAC/TC 136)
Pages:
12 pages
Scope
本文件规定了Rh血型C、c、E、e抗原检测卡(柱凝集法)的要求、试验方法、标签和使用说明书、包装、运输和贮存等。本文件适用于以凝胶、玻璃微珠等材料进行填充的微柱，微柱中抗C、c、E、e为IgM类型的单克隆抗体，采用免疫血液学、颗粒过筛和离心技术三者结合的原理，进行定性检测的Rh血型系统中C、c、E、e 4种抗原的检测试剂。本文件不适用于血源筛查进行Rh血型C、c、E、e抗原检测的诊断试剂。
Development Information
Drafting Units:
中国食品药品检定研究院、吉林省医疗器械检验研究院、长春博迅生物技术有限责任公司、江苏力博医药生物技术股份有限公司、迈克生物股份有限公司、伯乐生命医学产品(上海)有限公司、奥森多医疗器械贸易(中国)有限公司、北京九强生物技术股份有限公司
Drafting Persons:
胡泽斌、陈丽娟、陈维佳、王布强、王小波、侯磊、吕雄章、刘鹤、黄杰
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
JJG 204-1980
Active
JJG 204-1980 Meteorological Ventilation Psychrometer
SC 53-1980
Active
SC 53-1980 Transfer blade hydraulic steering gear repair quality standard
DZ 4-1981
Replaced
DZ 4-1981
SC 69-1982
Active
SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
Active