Vitros Immunodiagnostic Products Total PSA II - Taiwan Registration e1366be7c28af27f6028d599661f5d7b
Access comprehensive regulatory information for Vitros Immunodiagnostic Products Total PSA II in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e1366be7c28af27f6028d599661f5d7b and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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Device Details
Registration Details
e1366be7c28af27f6028d599661f5d7b
Ministry of Health Medical Device Import No. 025865
DHA05602586501
Product Details
This product is used to quantitatively detect the content of total prostate-specific antigen (free and conjugated, tPSA) in human serum and plasma (using heparin or EDTA as anticoagulants), and needs to be used with Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer and Vitex 5600 Biochemical Immunoassay Analyzer.
C Immunology and microbiology devices
C6010 Tumor-associated antigen immunoassay system
Imported from abroad
Dates and Status
Jan 27, 2014
Jan 27, 2024

