Taiwan FDA registration 5903a46b87e8041d5a6e6cc1170367ed

"Daishoulin" tumor marker CA 125 II radioimmunoassay reagent

TW: “代首林”腫瘤標記 CA 125 II 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: 5903a46b87e8041d5a6e6cc1170367ed
Customs Code: DHAS0601628000

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: In vitro testing methods were used to quantitatively detect the content of CA 125 (OC 125 defined antigen) in serum and EDTA plasma and heparin plasma.
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 CA 125 II 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 5903a46b87e8041d5a6e6cc1170367ed and manufactured by DIASORIN INC.;;DIASORIN S.P.A.. The authorized representative in Taiwan is TAIWAN LIFE SUPPORT SYSTEMS INC..

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