Taiwan FDA registration d4d52c3d7f99ba7cb5c0cfa6ac93e736
"Abbott" Alere NT-proBNP for Alinity i Reagent Kit
TW: "亞培" 美艾利爾N端B型利鈉胜肽前驅物檢驗試劑組
Taiwan·Risk Class 2·MD·Axis-Shield Diagnostics Limited·Registered Dec 26, 2019 – Dec 26, 2024ExpiredRegistration details
- Analysis ID
- d4d52c3d7f99ba7cb5c0cfa6ac93e736
- License Form
- Ministry of Health Medical Device Import No. 033117
- Customs Code
- DHA05603311707
Company information
- Manufacturer
- Axis-Shield Diagnostics Limited
- Manufacturer Country
- United Kingdom
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- This product is used for the in vitro quantitative detection of N-terminal B-type natriuretic peptide precursors (NT-proBNP) in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1117 Type B sodium urine peptide test system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 26, 2019
- Expiry Date
- Dec 26, 2024
About this record
Access comprehensive regulatory information for "Abbott" Alere NT-proBNP for Alinity i Reagent Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d4d52c3d7f99ba7cb5c0cfa6ac93e736 and manufactured by Axis-Shield Diagnostics Limited. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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