Taiwan FDA registration 4ff97fb763f4e95e52e81ccaa648c910

ID NOW Influenza A & B 2

TW: 艾迪納第二代流行性感冒病毒核酸檢驗試劑

Taiwan·Risk Class 2·MD·Abbott Diagnostics Scarborough, Inc.·Registered Jun 20, 2018 – Jun 20, 2028Active

Registration details

Analysis ID: 4ff97fb763f4e95e52e81ccaa648c910
License Form: Ministry of Health Medical Device Import No. 031305
Customs Code: DHA05603130501

Company information

Manufacturer: Abbott Diagnostics Scarborough, Inc.
Manufacturer Country: United States
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3980 Multi-standard nucleic acid test reagent for respiratory viruses
Import Information: Imported from abroad

Dates and status

Registration Date: Jun 20, 2018
Expiry Date: Jun 20, 2028

About this record

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..

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