Taiwan FDA registration a6ed32a22d8adba5554951be05c9497b

BIOPHEN APIXABAN CONTROL LOW

TW: 海分生醫APIXABAN品管液低值

Taiwan·Risk Class 2·MD·HYPHEN BioMed·Registered Mar 15, 2016 – Mar 15, 2026Expired

Registration details

Analysis ID: a6ed32a22d8adba5554951be05c9497b
License Form: Ministry of Health Medical Device Import No. 028296
Customs Code: DHA05602829600

Company information

Manufacturer: HYPHEN BioMed
Manufacturer Country: France
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: This product is a quality control solution containing two kinds of APIXABAN concentration of human plasmaban, which is used for quality control of measuring APIXABAN using anti-Xa colorimetric method.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 15, 2016
Expiry Date: Mar 15, 2026

About this record

Access comprehensive regulatory information for BIOPHEN APIXABAN CONTROL LOW in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a6ed32a22d8adba5554951be05c9497b and manufactured by HYPHEN BioMed. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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