Taiwan FDA registration f21c4f7be65009667ae1288c70811c00
and photovitamin K deficiency induction prothrombin test reagent
TW: 和光維生素K缺乏誘導凝血酶原檢驗試劑
Taiwan·Risk Class 2·Fujifilm Healthcare Manufacturing Corporation My Office Common Site·Registered Jul 26, 2016 – Jul 26, 2026ExpiredRegistration details
- Analysis ID
- f21c4f7be65009667ae1288c70811c00
- Customs Code
- DHA05602846408
Company information
- Manufacturer Country
- Japan
- Authorized Representative
- MEDICARE PRODUCTS INC.
Product details
- Intended Use
- This product is used for the determination of abnormal prothrombin (PIVKA-II) in serum (auxiliary diagnosis of HCC in hepatocyte cells).
- Product Type (Level 1)
- C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- C.6010 Mass phase antigen immunoassay system;; A.1150 Calibrated Products;; A.1660 Quality Material (Analysis Only)
- Import Information
- import
Dates and status
- Registration Date
- Jul 26, 2016
- Expiry Date
- Jul 26, 2026
About this record
Access comprehensive regulatory information for and photovitamin K deficiency induction prothrombin test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f21c4f7be65009667ae1288c70811c00 and manufactured by Fujifilm Healthcare Manufacturing Corporation My Office Common Site. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
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