Taiwan FDA registration 093cf1d4b6960bf8ee0af6b7ecd71315

"Daishoulin" tumor marker CA15-3 radioimmunoassay reagent

TW: “代首林”腫瘤標記 CA15-3放射免疫分析試劑

Taiwan·Risk Class 2·DIASORIN INC.;;DIASORIN S.P.A.·Registered Mar 31, 2006 – Mar 31, 2011Cancelled

Registration details

Analysis ID: 093cf1d4b6960bf8ee0af6b7ecd71315
Customs Code: DHAS0601627708

Company information

Manufacturer: DIASORIN INC.;;DIASORIN S.P.A.
Manufacturer Country: Italy;;United States
Authorized Representative: TAIWAN LIFE SUPPORT SYSTEMS INC.

Product details

Intended Use: Quantitatively measure the amount of CA15-3 antigen (DF3-defining antigen) in human serum.
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: Mar 31, 2006
Expiry Date: Mar 31, 2011
Cancellation Date: Nov 27, 2012

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Daishoulin" tumor marker CA15-3 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 093cf1d4b6960bf8ee0af6b7ecd71315 and manufactured by DIASORIN INC.;;DIASORIN S.P.A.. The authorized representative in Taiwan is TAIWAN LIFE SUPPORT SYSTEMS INC..

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