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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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e1366be7c28af27f6028d599661f5d7b
Registration Details
Taiwan FDA Registration: e1366be7c28af27f6028d599661f5d7b
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Device Details

Vitros Immunodiagnostic Products Total PSA II
TW: ็ถญ็‰นๅธ็ธฝๅ‰ๅˆ—่…บ็‰น็•ฐๆ€งๆŠ—ๅŽŸIIๅ…็–ซๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2
MD

Registration Details

e1366be7c28af27f6028d599661f5d7b

Ministry of Health Medical Device Import No. 025865

DHA05602586501

Company Information

United Kingdom

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