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Vites High Sensitivity Troponin I Immunoassay Kit - Taiwan Registration d8a8e21392f4c409f0d3d0d1a9110d17

Access comprehensive regulatory information for Vites High Sensitivity Troponin I Immunoassay Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d8a8e21392f4c409f0d3d0d1a9110d17 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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d8a8e21392f4c409f0d3d0d1a9110d17
Registration Details
Taiwan FDA Registration: d8a8e21392f4c409f0d3d0d1a9110d17
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Device Details

Vites High Sensitivity Troponin I Immunoassay Kit
TW: "็ถญ็‰นๅธ" ้ซ˜ๆ•ๆ„Ÿๆ€ง่‚Œ้ˆฃ่›‹็™ฝ I ๅ…็–ซๆชขๆธฌ่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

d8a8e21392f4c409f0d3d0d1a9110d17

DHA05603750701

Company Information

United Kingdom

Product Details

Quantitative determination of central troponin I (cTnI) in human serum and plasma (heparin) was performed using the Vitesus ECi/ECiQ/3600 immunodiagnostic analyzer and the Vitesus 5600/XT 7600 biochemical immunoassayer.

A Clinical chemistry and clinical toxicology

A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1150 calibration

Input;; QMS/QSD

Dates and Status

Oct 22, 2024

Oct 22, 2029