Vietnam MOH registration 230002524/PCBB-HN

Drug Test for Direct Bilirubin Quantification

VN: Thuốc thử xét nghiệm định lượng bilirubin trực tiếp
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Oct 05, 2023
Registration details
Analysis ID
230002524/PCBB-HN
Submission ID
000.00.19.H26-230926-0005
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Technical details
Intended Use
Direct Bilirubin Test is an in vitro diagnostic medical device, used by the professional staff in the colorimetric analysis to quantify the direct bilirubin in human serum and plasma on the Beckman Coulter AU/DxC AU automatic analyzers. The quantitative Direct Bilirubin test is used to support the diagnosis of liver function disorders.
Dates and status
Registration Date
Oct 05, 2023
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About this record

Access comprehensive regulatory information for Drug Test for Direct Bilirubin Quantification in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230002524/PCBB-HN and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Roche Diagnostics GmbH, Roche Diagnostics (Suzhou) Ltd., and 2 recent registrations in the same category. 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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