Qualitative Test Card for Legionella pneumophila Group 1
Vietnam·Risk Class TTBYT Loại C·BinaxNOW™ Legionella Urinary Antigen Card·Abbott Diagnostics Scarborough, Inc.·Registered Nov 02, 2024- Analysis ID
- 2403184ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230809-0004
- Product Type
- BinaxNOW™ Legionella Urinary Antigen Card
- Product Code
- 852-000
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
- Manufacturer Country
- UNITED STATES
- Product Owner
- Abbott Diagnostics Scarborough, Inc.
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- BinaxNOW™ Legionella Urinary Antigen Card (BinaxNOW Legionella) is an in vitro immunoassay test card that qualitatively detects the presence of Legionella pneumophila serogroup 1 (L. pneumophila serogroup 1 antigen) in urine samples from symptomatic pneumonia patients. The test is intended to aid in the presumptive diagnosis of Legionnaires' disease, a pneumonia caused by L. pneumophila serogroup 1, in combination with culture methods and other diagnostic methods.
- Registration Date
- Nov 02, 2024
Access comprehensive regulatory information for Qualitative Test Card for Legionella pneumophila Group 1 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 2403184ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Scarborough, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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