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China NMPA legacy archive 皖械注准20222400146

Serum tissue metalloproteinase inhibitor 1 determination reagent kit (latex turbidimetric method)

血清组织金属蛋白酶抑制因子1测定试剂盒(胶乳比浊法)
Anhui Daqian Bio-Engineering Limited CompanyClass IINMPAApproved June 24, 2022
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Approval department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration information
Registration number
皖械注准20222400146
Approval date
June 24, 2022
Expiry date
June 23, 2027
Registrant
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 facility
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
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

About this record

This static archive preserves historical registration fields and translations for Serum tissue metalloproteinase inhibitor 1 determination reagent kit (latex turbidimetric method), registration 皖械注准20222400146. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.