Taiwan FDA registration ca4188de2be73f6f0ec0192b46d9152a

Apex thyroglobulin antibody test set

TW: 亞培甲狀腺球蛋白抗體檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Nov 16, 2018 – Nov 16, 2028Active
Registration details
Analysis ID
ca4188de2be73f6f0ec0192b46d9152a
Customs Code
DHA05603178907
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
This product uses chemical cold light particle immunoassay (CMIA) with Alinity i analyzer to quantitatively detect IgG thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5870 甲狀腺自體抗體免疫試驗系統
Import Information
import
Dates and status
Registration Date
Nov 16, 2018
Expiry Date
Nov 16, 2028
About this record

Access comprehensive regulatory information for Apex thyroglobulin antibody test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ca4188de2be73f6f0ec0192b46d9152a and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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