Taiwan FDA registration 151dbc7340d540ffa608e49b19385039
Changying tumor antigen 125 reagent
TW: 常盈腫瘤抗原125試劑
Taiwan·Risk Class 2·IMMUNOTECH SAS, A BECKMAN COULTER COMPANY·Registered Jun 28, 2006 – Jun 28, 2016CancelledRegistration details
- Analysis ID
- 151dbc7340d540ffa608e49b19385039
- Customs Code
- DHAS0601716604
Company information
- Manufacturer
- IMMUNOTECH SAS, A BECKMAN COULTER COMPANY
- Manufacturer Country
- France
- Authorized Representative
- WOLCH ENTERPRISES INC.
Product details
- Intended Use
- Radioimmunoassay was used to detect CA125 in clinical serum and blood cells.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input
Dates and status
- Registration Date
- Jun 28, 2006
- Expiry Date
- Jun 28, 2016
- Cancellation Date
- Apr 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for Changying tumor antigen 125 reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 151dbc7340d540ffa608e49b19385039 and manufactured by IMMUNOTECH SAS, A BECKMAN COULTER COMPANY. The authorized representative in Taiwan is WOLCH ENTERPRISES INC..
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