Vietnam MOH registration 240003021/PCBB-HN

IVD Metabolic Renal Testing Cluster: Cortisol, Microalbumin, NGAL

VN: Cụm IVD xét nghiệm chuyển hóa thận: Cortisol, Microalbumin, NGAL

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Anbio (Xiamen) Biotechnology Co., Ltd.·Registered Nov 04, 2024

Registration details

Analysis ID: 240003021/PCBB-HN
Submission ID: 000.00.19.H26-241022-0031
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Anbio (Xiamen) Biotechnology Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Anbio (Xiamen) Biotechnology Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ VINDRAY

Technical details

Intended Use: Cor Rapid Test Kit is used together with the Anbio FIA Fluorescence Immunoassay Machine to quantitate the concentration of Cortisol (Cor) in whole blood, serum, or plasma of humans. / MAU Rapid Test Kit is used together with the Fluorescence Immunoassay Machine to quantitate the concentration of Microalbumin (MAU) in urine of humans. This test is primarily used as a supportive diagnostic tool for kidney damage/ NGAL Rapid Test Kit is used together with the Fluorescence Immunoassay Machine to quantitate the concentration of NGAL in urine of humans. This test is primarily used as a supportive diagnostic tool for kidney damage

Dates and status

Registration Date: Nov 04, 2024

About this record

Access comprehensive regulatory information for IVD Metabolic Renal Testing Cluster: Cortisol, Microalbumin, NGAL in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240003021/PCBB-HN and manufactured by Anbio (Xiamen) Biotechnology Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ VINDRAY.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.