Taiwan FDA registration 518a67ebce4b2f19eb927dba22c8f033
Roche immunoassay androstenedione test correction solution
TW: 羅氏免疫分析雄烯二酮檢驗試劑校正液
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Jul 10, 2024 – Jul 10, 2029ActiveRegistration details
- Analysis ID
- 518a67ebce4b2f19eb927dba22c8f033
- Customs Code
- DHA05603708705
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is intended for use on the cobas e immunoassay analyzer for calibration by the Elecsys Adrostenedione quantification method.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 Calibrated Products
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jul 10, 2024
- Expiry Date
- Jul 10, 2029
About this record
Access comprehensive regulatory information for Roche immunoassay androstenedione test correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 518a67ebce4b2f19eb927dba22c8f033 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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