Taiwan FDA registration 108200bbf4fc68d532fe6100d587cefc
"Siemens" enzyme creatinine test reagent
TW: “西門子” 酵素肌酸酐檢驗試劑
Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.;; Made (部分製程) in JAPAN·Registered Jun 30, 2023 – Jun 30, 2028ActiveRegistration details
- Analysis ID
- 108200bbf4fc68d532fe6100d587cefc
- Customs Code
- DHA05603619605
Company information
- Manufacturer Country
- United States;;Japan
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is intended for in vitro diagnostic use in conjunction with Atellica CH Analyzer for the quantitative detection of creatinine in human serum, plasma (heparin lithium and dipotassium EDTA) and urine.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jun 30, 2023
- Expiry Date
- Jun 30, 2028
About this record
Access comprehensive regulatory information for "Siemens" enzyme creatinine test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 108200bbf4fc68d532fe6100d587cefc and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.;; Made (部分製程) in JAPAN. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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