Vietnam MOH registration 240002587/PCBB-HN

Microalbumin Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng Microalbumin

Finecare™ One Step MAU Rapid Quantitative Test

Vietnam·Risk Class TBYT Loại B·One Step MAU Rapid Quantitative Test·Guangzhou Wondfo Biotech Co., Ltd.·Registered Oct 01, 2024

Registration details

Analysis ID: 240002587/PCBB-HN
Submission ID: 000.00.19.H26-240926-0004
Product Type: One Step MAU Rapid Quantitative Test
Product Code: W206

Company information

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Product Owner: Guangzhou Wondfo Biotech Co., Ltd.
Authorized Representative: CÔNG TY TNHH AVANTA DIAGNOSTICS

Technical details

Intended Use: Finecare™ One Step MAU Rapid Quantitative Test is a fluorescent immunoassay test used in conjunction with the Finecare™ FIA Fluorescent Immunoassay Machine (Models: FS-112, FS-113, FS-114, FS-205) to measure the quantitative amount of microalbuminuria (MAU) in urine samples from patients. The test is used as a diagnostic tool to assess kidney damage. It is intended for professional in-vitro diagnostic use only.

Dates and status

Registration Date: Oct 01, 2024

About this record

Access comprehensive regulatory information for Microalbumin Quantitative Testing Drug 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 240002587/PCBB-HN and manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

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