Pure Global

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.).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

Free Database
Powered by Pure Global AI
89,000+ Devices
64d60d7b6e6aefe22f7ee615a4d6139d
Registration Details
Taiwan FDA Registration: 64d60d7b6e6aefe22f7ee615a4d6139d
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

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

Registration Details

64d60d7b6e6aefe22f7ee615a4d6139d

DHA05603419506

Company Information

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

ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ;; QMS/QSD

Dates and Status

Jan 15, 2021

Jan 15, 2026