Creatinine Quantitative Testing Drug
- Analysis ID
- 240000301/PCBB-HN
- Submission ID
- 000.00.19.H26-240111-0003
- Product Type
- CREATININE (ENZYMATIC)
- Product Code
- OSR61204
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- 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.
- Registration Date
- Feb 05, 2024
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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.