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Abbott Designer CA 19-9XR Test Kit - Taiwan Registration 3a0e9924bdda0623ced86f36b9e3ce04

Access comprehensive regulatory information for Abbott Designer CA 19-9XR Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3a0e9924bdda0623ced86f36b9e3ce04 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.

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3a0e9924bdda0623ced86f36b9e3ce04
Registration Details
Taiwan FDA Registration: 3a0e9924bdda0623ced86f36b9e3ce04
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Device Details

Abbott Designer CA 19-9XR Test Kit
TW: ไบžๅŸน่จญ่จˆๅธซ CA 19-9XR ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

3a0e9924bdda0623ced86f36b9e3ce04

DHA05603624801

Company Information

Product Details

This product is used for the quantitative detection of 1116-NS-19-9 reaction determinants in human serum or plasma by chemically cold light particle immunoassay (CMIA) on the ARCHITECT i system.

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products

่ผธๅ…ฅ;; QMS/QSD;; ๅง”่จ—่ฃฝ้€ 

Dates and Status

Dec 27, 2023

Dec 27, 2028