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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Device Details
Registration Details
51c339df70a350a9a55726e644b7bead
DHA05603415405
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
ๅง่จ่ฃฝ้ ;; ่ผธๅ ฅ;; QMS/QSD
Dates and Status
Nov 09, 2020
Nov 09, 2025

