IVD virus-immunocompetent cluster - Vietnam Registration 240000055/PCBB-BYT
Access comprehensive regulatory information for IVD virus-immunocompetent cluster 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 240000055/PCBB-BYT and manufactured by Boditech Med Inc.. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Boditech Med 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
240000055/PCBB-BYT
000.00.04.G18-221114-0023
Theo theo phụ lục
Theo phụ lục
Technical Details
AFIAS NORO is a fluorescent immunoassay (FIA) test to determine the presence of norovirus in human feces. It is very useful in supporting the screening for norovirus infection. It is intended for in vitro diagnostic use only. AFIAS ROTA is a fluorescent immunoassay (FIA) test to determine the presence of rotavirus in human feces. It is useful in supporting the screening for rotavirus infection. It is intended for in vitro diagnostic use only. AFIAS Rota/Adeno is a fluorescent immunoassay (FIA) test to determine the presence of both rotavirus and adenovirus in human feces. It is very useful in supporting the management and monitoring of viral gastroenteritis. It is intended for in vitro diagnostic use only. Boditech NORO Control is designed to be used in in vitro diagnostic testing to control the quality of the Norovirus Test Kit. It is intended for in vitro diagnostic use only. Boditech ROTA Control is designed to be used in in vitro diagnostic testing to control the quality of the Rotavirus Test Kit. It is intended for in vitro diagnostic use only. Boditech Rota/Adeno Control is designed to control the quality of the Rota/Adenovirus Test Kit produced by Boditech Med Inc. It is intended for in vitro diagnostic use only. ichroma™ NORO is a fluorescent immunoassay (FIA) test to determine the presence of norovirus in human fecal samples. It is very useful in the screening for norovirus infection. It is intended for in vitro diagnostic use only. ichroma™ ROTA is a fluorescent immunoassay (FIA) test to determine the presence of rotavirus in human feces. It is very useful in supporting the screening for rotavirus infection. It is intended for in vitro diagnostic use only. ichroma™ Rota/Adeno is a fluorescent immunoassay (FIA) test to determine the presence of both rotavirus and adenovirus in human feces. It is very useful in supporting the management and monitoring of viral gastroenteritis. It is intended for in vitro diagnostic use only.
Dates and Status
Apr 10, 2024