Taiwan FDA registration 69c45dda2ed7fb3bfa98c6b6b957b216

Apex procalcitonin test set

TW: 亞培前降鈣素檢驗試劑組
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 Aug 22, 2019 – Aug 22, 2029Active
Registration details
Analysis ID
69c45dda2ed7fb3bfa98c6b6b957b216
Customs Code
DHA05603248301
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
The changed efficacy (adjusted textual description) is as follows: This product is used for the quantitative detection of procalcitonin (PCT) in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3210 內毒素分析試劑
Import Information
import
Dates and status
Registration Date
Aug 22, 2019
Expiry Date
Aug 22, 2029
About this record

Access comprehensive regulatory information for Apex procalcitonin 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 69c45dda2ed7fb3bfa98c6b6b957b216 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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