Pre-assay calcitonin test reagent for Roche immunoassay - Taiwan Registration 4d7b63a05b0589f6cecc4af30f593e75
Access comprehensive regulatory information for Pre-assay calcitonin test reagent for Roche immunoassay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4d7b63a05b0589f6cecc4af30f593e75 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Product Details
This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e immunoassay to quantitatively detect procalcitonin (PCT) in human serum and plasma in vitro.
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 01, 2023
Jun 01, 2028