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"Siemens" creatine kinase (CK_L) assay - Taiwan Registration 24eb2d8aa7494ad09a51de1bb5de8757

Access comprehensive regulatory information for "Siemens" creatine kinase (CK_L) assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 24eb2d8aa7494ad09a51de1bb5de8757 and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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24eb2d8aa7494ad09a51de1bb5de8757
Registration Details
Taiwan FDA Registration: 24eb2d8aa7494ad09a51de1bb5de8757
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Device Details

"Siemens" creatine kinase (CK_L) assay
TW: โ€œ่ฅฟ้–€ๅญโ€ ่‚Œ้…ธๆฟ€้…ถ(CK_L)ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

24eb2d8aa7494ad09a51de1bb5de8757

DHA05603199306

Company Information

Product Details

This product is used in vitro diagnostics with Atellica CH Analyzer to quantitatively detect creatine kinase activity in human plasma (heparin lithium) or serum.

A Clinical chemistry and clinical toxicology

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

import

Dates and Status

Dec 28, 2018

Dec 28, 2028