Taiwan FDA registration 24eb2d8aa7494ad09a51de1bb5de8757

"Siemens" creatine kinase (CK_L) assay

TW: “西門子” 肌酸激酶(CK_L)檢驗試劑

Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Dec 28, 2018 – Dec 28, 2028Active

Registration details

Analysis ID: 24eb2d8aa7494ad09a51de1bb5de8757
Customs Code: DHA05603199306

Company information

Manufacturer: RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: This product is used in vitro diagnostics with Atellica CH Analyzer to quantitatively detect creatine kinase activity in human plasma (heparin lithium) or serum.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
Import Information: import

Dates and status

Registration Date: Dec 28, 2018
Expiry Date: Dec 28, 2028

About this record

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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