China NMPA legacy archive 粤械注准20252400193抗肝/肾微粒体1型IgG抗体测定试剂盒（化学发光法）
- Device class
- Class II
- Model specifications
- 2×50 servings/box
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20252400193
- Approval date
- February 06, 2025
- Expiry date
- February 05, 2030
- Province/Region
- Guangdong
- Address
- Building 1, Yahuilong Biotechnology Factory, Baolong 2nd Road, Baolong Street, Longgang District, Shenzhen
- Production address
- 深圳市龙岗区宝龙街道宝龙二路亚辉龙生物科技厂区2栋
用于体外定量测定人血清和（或）血浆中抗肝/肾微粒体1型IgG抗体（LKM-1 IgG）的含量。临床上主要用于辅助诊断II型自身免疫性肝炎。
主要由试剂1（R1）、试剂2（R2）、试剂3（R3）、试剂4（R4）、校准品1（CAL1）、校准品2（CAL2）、校准品3（CAL3）组成。具体组分详见产品说明书。
Reagents and calibrators are stored vertically unopened at 2~8°C: stable for 18 months. Reagents and calibrators are stored at 2~8°C after first use: stable for 28 days. The reagent is stored at 2~8°C: it can be stable for 28 days. The calibrator can be stored stably for 8 hours at room temperature (20~25°C).
试剂及校准品未开封竖直存放于2～8℃：可稳定18个月。试剂及校准品首次使用后存放于2～8℃：可稳定28天。试剂2～8℃在机存放：可稳定28天。校准品在室温（20～25℃）下，可稳定保存8小时。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for 抗肝/肾微粒体1型IgG抗体测定试剂盒（化学发光法）, registration 粤械注准20252400193. It does not establish current authorization or complete current product details.
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