BinaxNOW Influenza A & B Card 2 - Taiwan Registration 616bb2b0870575c10d76231266ca45a2
Access comprehensive regulatory information for BinaxNOW Influenza A & B Card 2 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 616bb2b0870575c10d76231266ca45a2 and manufactured by Abbott Diagnostics Scarborough, Inc.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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Device Details
Registration Details
616bb2b0870575c10d76231266ca45a2
Ministry of Health Medical Device Import No. 033282
DHA05603328209
Product Details
This product is an in vitro immunochromocytometry method for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swabs and nasal swab samples. It is used to aid in the rapid differential diagnosis of influenza A and B virus infection. A negative test result is assumed and should be confirmed by cell culture or molecular assays for influenza A and B. A negative test result does not exclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. This product must be read by DIGIVAL.
C Immunology and microbiology devices
C3328 Influenza Virus Antigen Rapid Screening System
Imported from abroad
Dates and Status
Mar 02, 2020
Mar 02, 2025