Taiwan FDA registration e4dacdf018b9fb152fdb1c39bc49dc72

Changying tumor-associated antigen 15-3 radioimmunoassay reagent

TW: 常盈腫瘤相關抗原15-3放射免疫檢驗試劑

Taiwan·Risk Class 2·IMMUNOTECH SAS, A BECKMAN COULTER COMPANY·Registered Jun 28, 2006 – Jun 28, 2016Cancelled

Registration details

Analysis ID: e4dacdf018b9fb152fdb1c39bc49dc72
Customs Code: DHAS0601716808

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 CA15-3 antigen in blood/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: Input;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)

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-associated antigen 15-3 radioimmunoassay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e4dacdf018b9fb152fdb1c39bc49dc72 and manufactured by IMMUNOTECH SAS, A BECKMAN COULTER COMPANY. The authorized representative in Taiwan is WOLCH ENTERPRISES INC..

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