Taiwan FDA registration 1ed93f64e0bcf10e1fae5a0967d582de

Calibration solution and quality control solution of the pro-apex calcitonin test group

TW: 亞培前降鈣素檢驗試劑組之校正液與品管液
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 Oct 22, 2019 – Oct 22, 2029Active
Registration details
Analysis ID
1ed93f64e0bcf10e1fae5a0967d582de
Customs Code
DHA05603294704
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
Calibration solution: This product calcitonin (PCT) is used to calcitonin (PCT) in human serum and plasma to calibrate the Alinity i analyzer. Quality control solution: This product evaluates the test precision of Alinity i analyzer and detects system analysis deviations when quantitatively detecting procalcitonin (PCT) in human serum and plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
Contract manufacturing;; input
Dates and status
Registration Date
Oct 22, 2019
Expiry Date
Oct 22, 2029
About this record

Access comprehensive regulatory information for Calibration solution and quality control solution of the pro-apex calcitonin test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1ed93f64e0bcf10e1fae5a0967d582de 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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