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China NMPA legacy archive 皖械注准20202400568

Type III collagen test kit (latex-enhanced immunoturbidimetry method)

Ⅲ型胶原蛋白测定试剂盒(胶乳增强免疫比浊法)
Anhui Daqian Bio-Engineering Limited CompanyClass IINMPAApproved December 18, 2020
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20202400568
Approval date
December 18, 2020
Expiry date
December 17, 2025
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 type III. collagen (III.C) content in human serum or plasma in vitro.

中文

用于体外定量检测人血清或血浆中Ⅲ型胶原蛋白(ⅢC)的含量。

Structure and composition
English

R1: Tris buffer 100 mmol/L R2: Anti-human type III collagen antibody latex granules 2.1% Calibrators and quality controls: Type III collagen (optional

中文

R1: Tris缓冲液 100 mmol/L R2: 抗人Ⅲ型胶原蛋白抗体胶乳颗粒 2.1% 校准品、质控品:Ⅲ型胶原蛋白(选配

Storage conditions and expiration
English

The reagent can be stable for 18 months when stored in the dark at 2 °C ~ 8 °C to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.

中文

试剂于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 Type III collagen test kit (latex-enhanced immunoturbidimetry method), registration 皖械注准20202400568. 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.