IVD Department for Quantitative RF Testing - Vietnam Registration 230003102/PCBB-HN
Access comprehensive regulatory information for IVD Department for Quantitative RF Testing 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 230003102/PCBB-HN and manufactured by Theo theo phụ lục.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Beckman Coulter, Inc., and 1 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.
Device Details
Registration Details
230003102/PCBB-HN
000.00.19.H26-231116-0028
Theo theo phụ lục
Theo phụ lục
Technical Details
- RF Quantitative Test Reagent: A reagent used in in vitro diagnostic tests to automatically quantify the concentration of Rheumatoid Factor (RF) in the blood serum samples of patients. The product is packaged for use with the Beckman Coulter AU biochemical flow analysis machine. - RF Quantitative Test Calibration Standard: A calibration standard used to establish reference curves for determining the quantitative levels of RF tests using the Medicon reagent. - For in vitro diagnostic use by trained laboratory specialists only.
Dates and Status
Nov 23, 2023