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Retinol binding protein determination reagent kit (latex immunoturbidimetric assay) - NMPA Registration 冀械注准20142400288

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 冀械注准20142400288 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on November 07, 2019.

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

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Class II
冀械注准20142400288
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)
NMPA Registration Number: 冀械注准20142400288
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Intended Use
English

It is used for the quantitative determination of retinol-binding protein (RBP) content in human serum or urine in vitro.

中文

用于体外定量测定人血清或尿液中视黄醇结合蛋白(RBP)的含量。

Device Classification
Device Class
Class II
Approval Department
Hebei Food and Drug Administration
河北省食品药品监督管理局
Registration Information
Registration Number
冀械注准20142400288
Approval Date
November 07, 2019
Expiry Date
November 06, 2024
Registrant
Name
Langfang Hengyi Biotechnology Co., Ltd.
廊坊恒益生物技术有限公司
Province/Region
Hebei
河北
Address
No. 1, Yilan Road, Yongqing Taiwan New Industrial City, Langfang City, Hebei Province
河北省廊坊市永清台湾工业新城宜兰道1号
Production Facility
Production Address
河北省廊坊市永清台湾工业新城宜兰道1号
Structure and Composition
English

Reagent 1: phosphate buffer, 40 mmol/L; Polyethylene glycol 6000, 83mmol/L. Reagent 2: phosphate buffer, 40 mmol/L; Sheep anti-human RBP antiserum, ≥ 50mg/L.

中文

试剂1:磷酸盐缓冲液,40mmol/L;聚乙二醇6000,83mmol/L。试剂2:磷酸盐缓冲液,40mmol/L;羊抗人RBP抗血清,≥50mg/L。