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Alere HIV Combo - Taiwan Registration ede937838643ca6d6fa681372f646f71

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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ede937838643ca6d6fa681372f646f71
Registration Details
Taiwan FDA Registration: ede937838643ca6d6fa681372f646f71
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Device Details

Alere HIV Combo
TW: โ€œ็พŽ่‰พๅˆฉ็ˆพโ€ ๅพŒๅคฉๅ…็–ซไธๅ…จ็—…ๆฏ’ไบŒๅˆไธ€ๆชข้ฉ—่ฉฆ็ด™
Risk Class 3
MD

Registration Details

ede937838643ca6d6fa681372f646f71

Ministry of Health Medical Device Import No. 029503

DHA05602950300

Company Information

Product Details

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.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Feb 22, 2017

Feb 22, 2022