Taiwan FDA registration 76eee336317573216d908908a9f72993
Vitex biochemical product alanine transaminase-aspartate transaminase test tablets
TW: 維特司生化產品丙胺酸轉胺酶-天門冬胺酸轉胺酶試藥片
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Apr 19, 2021 – Apr 19, 2026ExpiredRegistration details
- Analysis ID
- 76eee336317573216d908908a9f72993
- Customs Code
- DHA05603439807
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- This product is an in vitro diagnostic reagent with VITROS XT 7600 automatic biochemical immunoassay analyzer or VITROS XT 3400 automatic biochemical analyzer, ALTV test piece and AST test piece to quantify alanine aminotransferase (ALT) activity and aspartate aminotransferase (AST) activity in serum and plasma, respectively.
- 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;; A.1030 丙胺酸轉胺酶試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Apr 19, 2021
- Expiry Date
- Apr 19, 2026
About this record
Access comprehensive regulatory information for Vitex biochemical product alanine transaminase-aspartate transaminase test tablets in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 76eee336317573216d908908a9f72993 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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