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Calibration solution and quality control solution of Abbott Designer B type natriuretic peptide test set - Taiwan Registration 51c339df70a350a9a55726e644b7bead

Access comprehensive regulatory information for Calibration solution and quality control solution of Abbott Designer B type natriuretic peptide 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 51c339df70a350a9a55726e644b7bead and manufactured by FUJIREBIO DIAGNOSTICS, INC.;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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51c339df70a350a9a55726e644b7bead
Registration Details
Taiwan FDA Registration: 51c339df70a350a9a55726e644b7bead
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Device Details

Calibration solution and quality control solution of Abbott Designer B type natriuretic peptide test set
TW: ไบžๅŸน่จญ่จˆๅธซBๅž‹ๅˆฉ้ˆ‰่ƒœ่‚ฝๆชข้ฉ—่ฉฆๅŠ‘็ต„ไน‹ๆ กๆญฃๆถฒๅŠๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

51c339df70a350a9a55726e644b7bead

DHA05603415405

Company Information

Product Details

Calibration Solution: This product is used to calibrate the ARCHITECT i system for the quantitative detection of human B-type natriuretic peptide (BNP) in human EDTA plasma. Quality control solution: This product is used to evaluate the test precision of the ARCHITECT i system (reagent, correction solution and instrument) and detect the analysis deviation of the ARCHITECT i system (reagent, correction solution and instrument) when quantifying the detection of human B-type natriuretic peptide (BNP) in human EDTA plasma.

A Clinical chemistry and clinical toxicology

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

ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ;; QMS/QSD

Dates and Status

Nov 09, 2020

Nov 09, 2025