Qualitative Test for SARS-CoV-2 Antigen
Vietnam·Risk Class TBYT Loại C·STANDARD™ Q COVID-19 Ag Home Test·SD Biosensor, Inc.·Registered Nov 14, 2024- Analysis ID
- 2403547ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231117-0009
- Product Type
- STANDARD™ Q COVID-19 Ag Home Test
- Product Code
- Theo phụ lục
- Manufacturer
- SD Biosensor, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- SD Biosensor, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
- Intended Use
- STANDARD™ Q COVID-19 Ag Home Test is a qualitative flow-through lateral flow test for the detection of nucleocapsid antigen in human nasal swab samples. The test is used to detect the antigens of SARS-CoV-2 in individuals suspected of being infected with COVID-19. The product is designed for self-testing by patients.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for Qualitative Test for SARS-CoV-2 Antigen in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403547ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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