Qualitative Test Card for Legionella pneumophila Group 1 - Vietnam Registration 2403184ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403184ĐKLH/BYT-HTTB
000.00.04.G18-230809-0004
BinaxNOW™ Legionella Urinary Antigen Card
852-000
Technical Details
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.
Dates and Status
Nov 02, 2024