Quantitative HbA1c Control Testing Material - Vietnam Registration 230000331/PCBB-BYT
Access comprehensive regulatory information for Quantitative HbA1c Control Testing Material 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 230000331/PCBB-BYT and manufactured by SD Biosensor, Inc..
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Ortho-Clinical Diagnostics, Inc., ARKRAY Factory, Inc., 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.
Device Details
Registration Details
230000331/PCBB-BYT
000.00.04.G18-230825-0003
SDB HbA1c Control
C-A1C
Technical Details
The SDB HbA1c Control is designed to control the performance of the STANDARD™ A1cCare, Multicare™, or STANDARD™ F systems for HbA1c testing. To maintain the quality of the test, it is recommended to perform at least two levels of control material concentration control at the facility on a regular basis. Quality control testing must be performed in accordance with the specified requirements and standard procedures of each laboratory.
Dates and Status
Aug 25, 2023