Serum tissue metalloproteinase inhibitor 1 determination reagent kit (latex turbidimetric method)
- Device class
- Class II
- Approval department
- Anhui Provincial Drug Administration安徽省药品监督管理局
- Registration number
- 皖械注准20222400146
- Approval date
- June 24, 2022
- Expiry date
- June 23, 2027
- Name
- Anhui Daqian Bio-Engineering Limited Company安徽大千生物工程有限公司
- Province/Region
- Anhui安徽
- Address
- Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
- Production address
- 安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
It is used for the quantitative detection of serum tissue metalloproteinase inhibitory factor I (TIMP-1) in human serum or plasma in vitro, and is mainly used clinically for the auxiliary diagnosis of liver fibrosis.
用于体外定量检测人血清或血浆中血清组织金属蛋白酶抑制因子I（TIMP-1）的含量，临床上主要用于肝纤维化的辅助诊断。
Composition Composition Concentration Reagent 1(R1) Tris buffer 100mmol/L Reagent 2(R2) Tris buffer 100mmol/L anti-human TIMP-I antibody latex granules 1.6% calibrator (optional): serum tissue metalloproteinase inhibitor I, phosphate buffer; Controls (optional): serum tissue metalloproteinase inhibitory factor I, phosphate buffer.
组成 成分 浓度试剂 1（R1） Tris 缓冲液 100mmol/L试剂 2（R2）Tris 缓冲液 100mmol/L抗人 TIMP-I 抗体胶乳颗粒1.6%校准品（选配）：血清组织金属蛋白酶抑制因子 I、磷酸盐缓冲液；质控品（选配）：血清组织金属蛋白酶抑制因子 I、磷酸盐缓冲液。
2°C~8°C storage in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.
2℃～8℃避光贮存可稳定 18 个月，防止冷冻。开瓶后于 2℃～8℃贮存可稳定 30天。
Access comprehensive regulatory information for Serum tissue metalloproteinase inhibitor 1 determination reagent kit (latex turbidimetric method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20222400146 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on June 24, 2022.
This page provides complete registration details including registrant information, province location (Anhui), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.