Taiwan FDA registration bd9cc5692f41579c27dc10bc2f238638
"Siemens" procalcitonin reagent group
TW: "西門子" 前降鈣素試劑組
Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Sep 07, 2022 – Sep 07, 2027ActiveRegistration details
- Analysis ID
- bd9cc5692f41579c27dc10bc2f238638
- Customs Code
- DHA05603570001
Company information
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Manufacturer Country
- United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- For in vitro diagnostics, this product needs to be used with ADVIA Centaur XP Analvzer, ADVIA Centaur XPT Analvzer or ADVIA Centaur CP Analvzer to quantitatively detect precalcitonin (PCT) in human serum and plasma (EDTA, lithium heparin and sodium heparin).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3210 內毒素分析試劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 07, 2022
- Expiry Date
- Sep 07, 2027
About this record
Access comprehensive regulatory information for "Siemens" procalcitonin reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bd9cc5692f41579c27dc10bc2f238638 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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