Taiwan FDA registration 11d5b853d31ea8585568261a1bdfdaeb
Roche Cobas aspartate aminotransferase second-generation biochemical assay reagent
TW: 羅氏可霸斯天門冬酸氨基轉移酶第二代生化檢驗試劑
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Jan 21, 2022 – Jan 21, 2027ActiveRegistration details
- Analysis ID
- 11d5b853d31ea8585568261a1bdfdaeb
- Customs Code
- DHA05603521007
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is an in vitro diagnostic test for the quantitative detection of aspartate aminotransferase (AST) in human serum and plasma with the COBAS C 303/503/703 system (this test uses phosphopyridoxal activation).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1100 天門冬胺酸轉胺酶試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 21, 2022
- Expiry Date
- Jan 21, 2027
About this record
Access comprehensive regulatory information for Roche Cobas aspartate aminotransferase second-generation biochemical assay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 11d5b853d31ea8585568261a1bdfdaeb and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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