Taiwan FDA registration a19b49bf8967f1e9a1e32f8f93e29972
Roche immunoassay cerebrospinal fluid phosphorylated tao protein (181P) test reagent
TW: 羅氏免疫分析腦脊髓液磷酸化濤蛋白(181P)檢驗試劑
Taiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH·Registered Feb 23, 2024 – Feb 23, 2029ActiveRegistration details
- Analysis ID
- a19b49bf8967f1e9a1e32f8f93e29972
- Customs Code
- DHA05603706304
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- 本產品利用電化學發光免疫分析法(ECLIA),體外定量檢測人類腦脊髓液中的磷酸化濤蛋白(phosphorylated Tau Protein) 濃度.
- 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
- Feb 23, 2024
- Expiry Date
- Feb 23, 2029
About this record
Access comprehensive regulatory information for Roche immunoassay cerebrospinal fluid phosphorylated tao protein (181P) 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 a19b49bf8967f1e9a1e32f8f93e29972 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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