China NMPA legacy archive 粤械注准20252400018Progesterone detection reagent kit (chemiluminescence immunoassay method)
- Device class
- Class II
- Model specifications
- Model A: 50 servings/box, 2×50 servings/box, 100 servings/box, 2×100 servings/box, 4×100 servings/box, Model F: 25 servings/box, 2×25 servings/box, 50 servings/box, 2×50 servings/box, 3×50 servings/box, 4×50 servings/box.
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20252400018
- Approval date
- January 06, 2025
- Expiry date
- January 05, 2030
- Province/Region
- Guangdong
- Address
- No. 8, Lizhishan Road, Science City, Huangpu District, Guangzhou
- Production address
- 广州市黄埔区科学城荔枝山路8号；广州市黄埔区神舟路268号
用于体外定量测定人体血清和血浆中孕酮的含量。临床上主要用于先兆流产的辅助诊断。
试剂盒主要由磁珠包被物(R1)、酶标记物(R2)、样本处理液（R3）、校准品和质控品（选配）组成。其中磁珠包被物(R1)包含包被着羊抗孕酮单克隆抗体的磁性微粒；Tris 缓冲液；ProClin 300。酶标记物(R2)包含孕酮抗原的碱性磷酸酶标记物；MES 缓冲液；ProClin 300。样本处理液（R3）包含Tris 缓冲液；ProClin 300。校准品包含不同浓度的孕酮纯品抗原，冻干粉。质控品（选配）包含不同浓度的孕酮纯品抗原，冻干粉。
试剂盒：2～8℃保存，未开封有效期18个月，开封2～8℃稳定性为28天。禁止冷冻。校准品和质控品：2～8℃避光保存，未开封有效期18个月；开封复溶后，在室温（18～25℃）环境下可稳定8小时；在-20℃±5℃贮存环境下有效期为30天，冻融次数不超过1次。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Progesterone detection reagent kit (chemiluminescence immunoassay method), registration 粤械注准20252400018. It does not establish current authorization or complete current product details.
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