Qualitative Test for SARS-CoV-2 Antigen, Influenza A and/or Influenza B
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Abbott Rapid Dx Galway·Registered Nov 02, 2024- Analysis ID
- 2403121ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240314-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Abbott Rapid Dx Galway
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Abbott Rapid Dx Galway
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- The Panbio™ COVID-19/Flu A&B Panel (Nasal) is an in vitro diagnostic test for the qualitative detection of SARS-CoV-2 nucleocapsid protein and Influenza A&B nucleoprotein antigens in specimens from the nasal mid-turbinate (NMT) swab of symptomatic individuals who meet the clinical and/or epidemiological criteria for COVID-19 and/or Flu. The Panbio™ COVID-19/Flu A&B Panel (Nasal) is intended for use by trained professionals in a laboratory setting and near the patient to support the diagnosis of SARS-CoV-2 and Flu. This test is not intended for self-testing. This test is not automated. The test provides a preliminary test result. A negative result does not rule out the possibility of SARS-CoV-2 and Influenza A&B infections and should not be used as the sole basis for treatment or other control decisions. A negative result must be interpreted in conjunction with clinical observations, patient history, and epidemiological information.
- Registration Date
- Nov 02, 2024
Access comprehensive regulatory information for Qualitative Test for SARS-CoV-2 Antigen, Influenza A and/or Influenza B in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403121ĐKLH/BYT-HTTB and manufactured by Abbott Rapid Dx Galway. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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