Taiwan FDA registration 6a84b12c16cc8edfbc4b42452e939aad

"100 first" alpha-fetal protein radioimmunoassay reagents

TW: “百首”甲胎兒蛋白放射免疫分析試劑

Taiwan·Risk Class 2·DIASOURCE IMMUNOASSAYS S.A.·Registered Mar 24, 2009 – Mar 24, 2014Cancelled

Registration details

Analysis ID: 6a84b12c16cc8edfbc4b42452e939aad
Customs Code: DHAS0601996801

Company information

Manufacturer: DIASOURCE IMMUNOASSAYS S.A.
Manufacturer Country: Belgium
Authorized Representative: TAIWAN LIFE SUPPORT SYSTEMS INC.

Product details

Intended Use: It is used for the quantitative detection of alpha-fetoprotein (AFP) in human serum and plasma in vitro.
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 24, 2009
Expiry Date: Mar 24, 2014
Cancellation Date: Sep 26, 2016

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "100 first" alpha-fetal protein radioimmunoassay reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6a84b12c16cc8edfbc4b42452e939aad and manufactured by DIASOURCE IMMUNOASSAYS S.A.. The authorized representative in Taiwan is TAIWAN LIFE SUPPORT SYSTEMS INC..

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