Taiwan FDA registration 1665c67591119e309e42b8eeeedb1038
"Abbott" drops acquired immunodeficiency virus two-in-one test strip
TW: “亞培” 滴就靈後天免疫不全病毒二合一檢驗試紙
Taiwan·Risk Class 3·ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT·Registered Oct 08, 2021 – Oct 08, 2026ActiveRegistration details
- Analysis ID
- 1665c67591119e309e42b8eeeedb1038
- Customs Code
- DHA05603491106
Company information
- Manufacturer
- ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product is an in vitro, visually interpretable and qualitative immunoassay that simultaneously detects HIV-1 and HIV-2 antibodies (Ab) and non-immune complex (free) HIV-1 p24 antigen (Ag) in human fingertip microvascular and venous whole blood, plasma or serum.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 08, 2021
- Expiry Date
- Oct 08, 2026
About this record
Access comprehensive regulatory information for "Abbott" drops acquired immunodeficiency virus two-in-one test strip in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 1665c67591119e309e42b8eeeedb1038 and manufactured by ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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