Taiwan FDA registration 59d761631f733742b45559d443f73767
Roche immunoassay β amyloid (1-42) cerebrospinal fluid II test reagents
TW: 羅氏免疫分析β類澱粉蛋白(1-42)腦脊髓液 II 檢驗試劑
Taiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH·Registered Oct 16, 2023 – Oct 16, 2028ActiveRegistration details
- Analysis ID
- 59d761631f733742b45559d443f73767
- Customs Code
- DHA05603622907
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is used to quantify the concentration of β-amyloid (1-42) (β-Amyloid) in human cerebrospinal fluid by electrochemiluminescence immunoassay (ECLIA) in vitro.
- 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 16, 2023
- Expiry Date
- Oct 16, 2028
About this record
Access comprehensive regulatory information for Roche immunoassay β amyloid (1-42) cerebrospinal fluid II test reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 59d761631f733742b45559d443f73767 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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