Taiwan FDA registration 4ed1cc044eba955cde79dc94bbdff7c5
Roche immunoassay cerebrospinal fluid total Tao protein test reagent
TW: 羅氏免疫分析腦脊髓液總濤蛋白檢驗試劑
Taiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH·Registered Nov 28, 2023 – Nov 28, 2028ActiveRegistration details
- Analysis ID
- 4ed1cc044eba955cde79dc94bbdff7c5
- Customs Code
- DHA05603623808
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is an in vitro quantitative inspection of the concentration of Total Tau Protein in human parietal spinal fluid using Electrochemical Emission Immunoassay (ECLIA).
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; C.9999 Miscellaneous
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Nov 28, 2023
- Expiry Date
- Nov 28, 2028
About this record
Access comprehensive regulatory information for Roche immunoassay cerebrospinal fluid total Tao protein test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4ed1cc044eba955cde79dc94bbdff7c5 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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