and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio assay kit - Taiwan Registration 685dba44d63d4c1d59b2c8a6cdba9d5b
Access comprehensive regulatory information for and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio assay kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 685dba44d63d4c1d59b2c8a6cdba9d5b and manufactured by Fujifilm Healthcare Manufacturing Corporation My Office Common Site. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Product Details
It is used for the determination of the heterogeneous ratio (AFP-L3%) and alpha-fetoprotein (AFP) concentration in serum. It can be used for auxiliary diagnosis of malignant tumors.
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 24, 2021
Jun 24, 2026