Taiwan FDA registration 00dc08e0f0f7c0c667f42630bba9ddc9
"Siemens" high sensitivity C-reactive protein reagent set
TW: “西門子” 高靈敏度C-反應蛋白試劑組
Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Jan 08, 2019 – Jan 08, 2029ActiveRegistration details
- Analysis ID
- 00dc08e0f0f7c0c667f42630bba9ddc9
- Customs Code
- DHA05603201000
Company information
- Manufacturer Country
- United Kingdom;;United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is used for in vitro diagnostics, and needs to be used with Atellica CH Analyzer to quantitatively detect the concentration of C-reactive protein (CPR) in human serum and plasma (heparin lithium, EDTA potassium salt).
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1150 校正品;; C.5270 C反應蛋白免疫試驗系統
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Jan 08, 2019
- Expiry Date
- Jan 08, 2029
About this record
Access comprehensive regulatory information for "Siemens" high sensitivity C-reactive protein reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 00dc08e0f0f7c0c667f42630bba9ddc9 and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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