Taiwan FDA registration 616bb2b0870575c10d76231266ca45a2

BinaxNOW Influenza A & B Card 2

TW: 拜奈克思流行性感冒二合一型病毒抗原快速診斷檢驗卡

Taiwan·Risk Class 2·MD·Abbott Diagnostics Scarborough, Inc.·Registered Mar 02, 2020 – Mar 02, 2025Expired

Registration details

Analysis ID: 616bb2b0870575c10d76231266ca45a2
License Form: Ministry of Health Medical Device Import No. 033282
Customs Code: DHA05603328209

Company information

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

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3328 Influenza Virus Antigen Rapid Screening System
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 02, 2020
Expiry Date: Mar 02, 2025

About this record

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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