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鄂械注准20242405161

Retinol binding protein determination reagent kit (latex immunoturbidimetric assay)

视黄醇结合蛋白测定试剂盒（胶乳免疫比浊法）
Wuhan Life Origin Biotech Joint Stock Co., Ltd.·Class II·NMPA·Approved September 02, 2024
Device classification
Device class
Class II
Model specifications
试剂1:60mL×3、试剂2:60mL×1;试剂1:18mL×1、试剂2:6mL×1;试剂1:60mL×1、试剂2:20mL×1;试剂1:80mL×3、试剂2:80mL×1;试剂1:90mL×2、试剂2:60mL×1;试剂1:80mL×6、试剂2:80mL×2;试剂1:50mL×3、试剂2:50mL×1;试剂1:60mL×6、试剂2:60mL×2;试剂1:40mL×3、试剂2:40mL×1;试剂1:60mL×12、试剂2:60mL×4;试剂1:30mL×2、试剂2:20mL×1;试剂1:90mL×3、 试剂2:90mL×1;试剂1:60mL×2、试剂2:40mL×1;试剂1:90mL×6、 试剂2:90mL×2;试剂1:120mL×3、试剂2:60mL×2;试剂1:120mL×6、试剂2:60mL×4;试剂1:120mL×5、试剂2:50mL×4;试剂1:6×64测试/盒、试剂2:6×64测试/盒;试剂1:12×64测试/盒、试剂2:12×64测试/盒;试剂1:24×64测试/盒、试剂2:24×64测试/盒;试剂1:1×530测试/盒、试剂2:1×530测试/盒;试剂1:36×64测试/盒、试剂2:36×64测试/盒;试剂1:4×530测试/盒、试剂2:4×530测试/盒;试剂1:2×530测试/盒、试剂2:2×530测试/盒;试剂1:8×530测试/盒、试剂2:8×530测试/盒;试剂1:6×530测试/盒、试剂2:6×530测试/盒;试剂1:2×480测试/盒、试剂2:2×480测试/盒;试剂1:12×530测试/盒、试剂2:12×530测试/盒;试剂1:1×180测试/盒、试剂2:1×180测试/盒; 试剂1:2×265测试/盒、试剂2:1×530测试/盒;试剂1:4mL×24(6×64测试/盒)、试剂2:2.7mL×12(6×64测试/盒).
试剂1:60mL×3、试剂2:60mL×1；试剂1:18mL×1、试剂2:6mL×1；试剂1:60mL×1、试剂2:20mL×1；试剂1:80mL×3、试剂2:80mL×1；试剂1:90mL×2、试剂2:60mL×1；试剂1:80mL×6、试剂2:80mL×2；试剂1:50mL×3、试剂2:50mL×1；试剂1:60mL×6、试剂2:60mL×2；试剂1:40mL×3、试剂2:40mL×1；试剂1:60mL×12、试剂2:60mL×4；试剂1:30mL×2、试剂2:20mL×1；试剂1:90mL×3、 试剂2:90mL×1；试剂1:60mL×2、试剂2:40mL×1；试剂1:90mL×6、 试剂2:90mL×2；试剂1:120mL×3、试剂2:60mL×2；试剂1:120mL×6、试剂2:60mL×4；试剂1:120mL×5、试剂2:50mL×4；试剂1:6×64测试/盒、试剂2:6×64测试/盒；试剂1:12×64测试/盒、试剂2:12×64测试/盒；试剂1:24×64测试/盒、试剂2:24×64测试/盒；试剂1:1×530测试/盒、试剂2:1×530测试/盒；试剂1:36×64测试/盒、试剂2:36×64测试/盒；试剂1:4×530测试/盒、试剂2:4×530测试/盒；试剂1:2×530测试/盒、试剂2:2×530测试/盒；试剂1:8×530测试/盒、试剂2:8×530测试/盒；试剂1:6×530测试/盒、试剂2:6×530测试/盒；试剂1:2×480测试/盒、试剂2:2×480测试/盒；试剂1:12×530测试/盒、试剂2:12×530测试/盒；试剂1:1×180测试/盒、试剂2:1×180测试/盒； 试剂1:2×265测试/盒、试剂2:1×530测试/盒；试剂1:4mL×24（6×64测试/盒）、试剂2:2.7mL×12（6×64测试/盒）。
Approval department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration information
Registration number
鄂械注准20242405161
Approval date
September 02, 2024
Expiry date
September 01, 2029
Registrant
Name
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
武汉生之源生物科技股份有限公司
Province/Region
Hubei
湖北
Address
1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼
Production facility
Production address
武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、3楼
Intended use
English

本品用于定量测定人体血清、血浆中视黄醇结合蛋白的含量.

中文

本品用于定量测定人体血清、血浆中视黄醇结合蛋白的含量。

Structure and composition
English

试剂1 :三羟甲基氨基甲烷、叠氮化钠;试剂2 :抗人RBP抗体的胶乳颗粒悬浊液.(具体内容详见产品说明书)

中文

试剂1 :三羟甲基氨基甲烷、叠氮化钠；试剂2 :抗人RBP抗体的胶乳颗粒悬浊液。（具体内容详见产品说明书）

Storage conditions and expiration
English

This product can be stable for 18 months when stored in a closed and dark manner at 2 °C ~ 8 °C.

中文

本品2℃～8℃密闭避光储存可稳定18个月。

Additional information
Appendix
产品技术要求、说明书
About this record

Access comprehensive regulatory information for Retinol binding protein determination reagent kit (latex immunoturbidimetric assay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鄂械注准20242405161 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on September 02, 2024.

This page provides complete registration details including registrant information, province location (Hubei), 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.