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Microalbumin Quantitative Testing Drug - Vietnam Registration 240002587/PCBB-HN

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.

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.

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240002587/PCBB-HN
Registration Details
Vietnam MOH Registration: 240002587/PCBB-HN
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Device Details

Microalbumin Quantitative Testing Drug
VN: Thuốc thử xét nghiệm định lượng Microalbumin
Finecare™ One Step MAU Rapid Quantitative Test
Risk Class TBYT Loại B

Registration Details

240002587/PCBB-HN

000.00.19.H26-240926-0004

One Step MAU Rapid Quantitative Test

W206

Company Information

Guangzhou Wondfo Biotech Co., Ltd.

Technical Details

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

Oct 01, 2024