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YY/T 1958-2025: 17α-Hydroxyprogesterone testing kit (Labelling immunoassay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1958-2025	English	189	Add to Cart	3 days [Need to translate]	17α-Hydroxyprogesterone testing kit (Labelling immunoassay)

YY/T 1958-2025: 17α-Hydroxyprogesterone testing kit (Labelling immunoassay)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.100.10 CCSC44 Pharmaceutical Industry Standards of the People's Republic of China 17α-Hydroxyprogesterone Assay Kit (Label-based immunoassay) Published on 2025-06-18 Implemented on July 1, 2026 National Medical Products Administration issued

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Shenzhen New Industries Biomedical Engineering Co., Ltd., Beijing Hospital, and Beijing Institute for Medical Device Testing. Institute (Beijing Medical Biological Protective Equipment Testing and Research Center), National Institute of Metrology, Shenzhen Yahuilong Biotechnology Co., Ltd. Company, Guangzhou Fenghua Biotechnology Co., Ltd., and Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. The main drafters of this document are. Wang Wenfeng, Zhang Tianjiao, Liu Yanchun, Song Dewei, Zhang Ji, Tan Yuhua, and Yu Songlin. 17α-Hydroxyprogesterone Assay Kit (Label-based immunoassay)

1 Scope

This document specifies the technical requirements, labeling, marking, and instructions for use of the 17α-hydroxyprogesterone assay kit (labeled immunoassay). The loading, transportation, and storage of the equipment are described, along with the corresponding testing methods. This document applies to the in vitro quantitative determination of human serum and blood using methods such as enzyme labeling, (electro)chemiluminescence labeling, and (time-resolved) fluorescent labeling. Immunoassay kit for 17α-hydroxyprogesterone content in plasma and heel blood (dried blood smears on filter paper). This document does not apply to. a) Immunochromatographic reagent kit; b) Calibrators and quality control products intended for separate sale.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 191 Pictorial Symbols for Packaging and Storage GB/T 21415 Metrological Traceability of Calibrators and Control Substances for the Measurement of Quantities in Biological Samples of In Vitro Diagnostic Medical Devices Source GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents

3 Terms and Definitions

This document does not contain any terms or definitions that need to be defined.

4 Requirements

4.1 Appearance The appearance must meet the following requirements. a) The reagent kit should have all components, intact inner and outer packaging, and clear, easily identifiable labels; b) There should be no leakage of liquid components. 4.2 Traceability Manufacturers shall provide information on the source, assignment process, and measurement uncertainty of 17α-hydroxyprogesterone calibrators in accordance with GB/T 21415 and relevant regulations. Content such as degree. 4.3 Limit of Detection For kits used to determine serum or plasma, the limit of detection should not exceed 0.1 ng/mL; for kits used to determine heel prick blood, the limit of detection should not exceed [missing value]. ...