Taiwan FDA registration ede937838643ca6d6fa681372f646f71
Alere HIV Combo
TW: “美艾利爾” 後天免疫不全病毒二合一檢驗試紙
Taiwan·Risk Class 3·MD·ALERE MEDICAL CO.,LTD CHIBA PLANT·Registered Feb 22, 2017 – Feb 22, 2022ExpiredRegistration details
- Analysis ID
- ede937838643ca6d6fa681372f646f71
- License Form
- Ministry of Health Medical Device Import No. 029503
- Customs Code
- DHA05602950300
Company information
- Manufacturer
- ALERE MEDICAL CO.,LTD CHIBA PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product is an invitro, 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 fingertips and venous whole blood, plasma or serum.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 22, 2017
- Expiry Date
- Feb 22, 2022
About this record
Access comprehensive regulatory information for Alere HIV Combo in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number ede937838643ca6d6fa681372f646f71 and manufactured by ALERE MEDICAL CO.,LTD CHIBA PLANT. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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