Calibration solution and quality control solution of Apex B type natriuretic peptide test group - Taiwan Registration 64d60d7b6e6aefe22f7ee615a4d6139d
Access comprehensive regulatory information for Calibration solution and quality control solution of Apex B type natriuretic peptide 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 64d60d7b6e6aefe22f7ee615a4d6139d 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
64d60d7b6e6aefe22f7ee615a4d6139d
DHA05603419506
Product Details
Calibration Solution: This product is used to calibrate the Alinity i Analyzer 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 Alinity i analyzer and detect system analysis deviations in the quantitative 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
Jan 15, 2021
Jan 15, 2026

