Vitros Immunodiagnostic Products Free PSA - Taiwan Registration af6085166681e12531dc83bafcfe6c3a
Access comprehensive regulatory information for Vitros Immunodiagnostic Products Free PSA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number af6085166681e12531dc83bafcfe6c3a and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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Device Details
Registration Details
af6085166681e12531dc83bafcfe6c3a
Ministry of Health Medical Device Import No. 025864
DHA05602586409
Product Details
The changed efficacy is: This product is used to quantitatively determine the content of free prostate-specific antigen (fPSA) in human serum and plasma (containing heparin or EDTA) samples using the Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer and Vitex 5600/XT7600 Biochemical Immunoassay Analyzer, and then combined with Vitex Total PSA II to convert the ratio of free prostate-specific antigen to total prostate-specific antigen (%fPSA).
C Immunology and microbiology devices
C6010 Tumor-associated antigen immunoassay system
Imported from abroad
Dates and Status
Jan 27, 2014
Jan 27, 2029