and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio determination correction solution and quality control solution - Taiwan Registration b1f9af75a40cf7ed98402b17d6e0bbff
Access comprehensive regulatory information for and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio determination correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b1f9af75a40cf7ed98402b17d6e0bbff and manufactured by FUJIFILM Wako Pure Chemical Corporation Mie Plant. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
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Device Details
Product Details
Calibration Solution: This product is designed to correct ฮผTASWako AFP-L3 reagent for the quantitative determination of AFP-L3% and AFP in human serum. Quality control solution: This product is designed as a quality control material for the quantitative determination of AFP-L3% and AFP in human serum with ฮผTASWako AFP-L3 reagent.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 13, 2023
Jun 13, 2028