Taiwan FDA registration 93d95bc26ad9f8323b77bb2ccf021137

Siemens creatine kinase panel

TW: 西門子肌酸激酶試劑組

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.·Registered May 05, 2017 – May 05, 2027Active

Registration details

Analysis ID: 93d95bc26ad9f8323b77bb2ccf021137
Customs Code: DHA05602955605

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.
Manufacturer Country: United Kingdom;;United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: Combined with ADVIA Chemical 1800, 2400 and XPT systems to quantitatively detect the activity of creatine kinase 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: Input;; Contract manufacturing

Dates and status

Registration Date: May 05, 2017
Expiry Date: May 05, 2027

About this record

Access comprehensive regulatory information for Siemens creatine kinase panel in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 93d95bc26ad9f8323b77bb2ccf021137 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; RANDOX LABORATORIES LTD.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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