Taiwan FDA registration 4a59d68c9f792fac837880818b1133d1

Emanutec MUC-1 gene-associated antigen (CA15-3) radioimmunoassay panel

TW: 伊曼紐特克MUC-1基因相關抗原(CA15-3)放射免疫分析試劑組

Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Dec 28, 2021 – Dec 28, 2026Active

Registration details

Analysis ID: 4a59d68c9f792fac837880818b1133d1
Customs Code: DHA05603492606

Company information

Manufacturer: IMMUNOTECH S.R.O.
Manufacturer Country: Czechia
Authorized Representative: MEGA BONA INTERNATIONAL CO., LTD.

Product details

Intended Use: In vitro measurement of MUC-1 gene-associated antigen (CA15-3) in human serum and plasma was measured by radioimmunoassay.
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 must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); QMS/QSD

Dates and status

Registration Date: Dec 28, 2021
Expiry Date: Dec 28, 2026

About this record

Access comprehensive regulatory information for Emanutec MUC-1 gene-associated antigen (CA15-3) radioimmunoassay panel in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4a59d68c9f792fac837880818b1133d1 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..

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