Vietnam MOH registration 240000301/PCBB-HN

Creatinine Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng creatinin
Vietnam flagVietnam·Risk Class TTBYT Loại B·CREATININE (ENZYMATIC)·FUJIFILM Wako Pure Chemical Corporation·Registered Feb 05, 2024
Registration details
Analysis ID
240000301/PCBB-HN
Submission ID
000.00.19.H26-240111-0003
Product Type
CREATININE (ENZYMATIC)
Product Code
OSR61204
Company information
Technical details
Intended Use
Enzymatic Creatinine Test is an in vitro diagnostic medical device used by medical specialists to quantify creatinine in serum, plasma, and urine of humans, using the enzymatic catalysis method on Beckman Coulter's AU/DxC AU automated analyzers. The measurement of creatinine is used to support the diagnosis and monitoring of kidney dysfunction conditions.
Dates and status
Registration Date
Feb 05, 2024
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About this record

Access comprehensive regulatory information for Creatinine Quantitative Testing Drug 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 240000301/PCBB-HN and manufactured by FUJIFILM Wako Pure Chemical Corporation. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Abbott Ireland Diagnostics Division, Ortho-Clinical Diagnostics Inc., and 4 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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