IVD virus-immunocompetent cluster
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Boditech Med Inc.·Registered Apr 10, 2024- Analysis ID
- 240000055/PCBB-BYT
- Submission ID
- 000.00.04.G18-221114-0023
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Boditech Med Inc.
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- 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.
- Registration Date
- Apr 10, 2024
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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.
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