Taiwan FDA registration df75001b3022361b97ba6d9a9bae1723

Apex thyroid peroxidase antibody test set

TW: 亞培甲狀腺過氧化酶抗體檢驗試劑組
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 06, 2018 – Nov 06, 2028Active
Registration details
Analysis ID
df75001b3022361b97ba6d9a9bae1723
Customs Code
DHA05603177601
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
This product is used on the Alinity i analyzer for the quantitative detection of thyroid peroxidase IgG autologous antibody (anti-TPO) in human serum and plasma by chemical cold light particle immunoassay (CMIA).
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 06, 2018
Expiry Date
Nov 06, 2028
About this record

Access comprehensive regulatory information for Apex thyroid peroxidase 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 df75001b3022361b97ba6d9a9bae1723 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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