ID NOW Influenza A & B 2 - Taiwan Registration 4ff97fb763f4e95e52e81ccaa648c910
Access comprehensive regulatory information for ID NOW Influenza A & B 2 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4ff97fb763f4e95e52e81ccaa648c910 and manufactured by Abbott Diagnostics Scarborough, Inc.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
4ff97fb763f4e95e52e81ccaa648c910
Ministry of Health Medical Device Import No. 031305
DHA05603130501
Product Details
Used in conjunction with Alere i Instrument, this product is a rapid molecular in vitro diagnostic test using isothermal nucleic acid amplification technology to qualitatively detect and identify influenza A and influenza B virus RNA in patients with signs and symptoms of respiratory tract infection with direct nasal or nasopharyngeal swabs taken by patients with signs and symptoms of respiratory infection and nasopharyngeal swabs laved with viral delivery medium. This product is combined with clinical and epidemiological risk factors and is suitable for assisting in the differential diagnosis of influenza virus infection type A and type B.
C Immunology and microbiology devices
C3980 Multi-standard nucleic acid test reagent for respiratory viruses
Imported from abroad
Dates and Status
Jun 20, 2018
Jun 20, 2028