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Calibration solution and quality control solution of the pro-apex calcitonin test group - Taiwan Registration 1ed93f64e0bcf10e1fae5a0967d582de

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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1ed93f64e0bcf10e1fae5a0967d582de
Registration Details
Taiwan FDA Registration: 1ed93f64e0bcf10e1fae5a0967d582de
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Device Details

Calibration solution and quality control solution of the pro-apex calcitonin test group
TW: ไบžๅŸนๅ‰้™้ˆฃ็ด ๆชข้ฉ—่ฉฆๅŠ‘็ต„ไน‹ๆ กๆญฃๆถฒ่ˆ‡ๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

1ed93f64e0bcf10e1fae5a0967d582de

DHA05603294704

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

Contract manufacturing;; input

Dates and Status

Oct 22, 2019

Oct 22, 2029