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Abbotel Human Paratestosterone 4 Test Set - Taiwan Registration 1038603dc6a45a9cab70bb1c5b50ffc7

Access comprehensive regulatory information for Abbotel Human Paratestosterone 4 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 1038603dc6a45a9cab70bb1c5b50ffc7 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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1038603dc6a45a9cab70bb1c5b50ffc7
Registration Details
Taiwan FDA Registration: 1038603dc6a45a9cab70bb1c5b50ffc7
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Device Details

Abbotel Human Paratestosterone 4 Test Set
TW: ไบžๅŸนไบบ้กžๅ‰ฏ็ช่›‹็™ฝ่ณช4ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

1038603dc6a45a9cab70bb1c5b50ffc7

DHA05603147408

Company Information

Product Details

This product is used to quantitatively detect HE4 antigen in human serum by chemical cold light microparticle immunoassay (CMIA) on the Alinity i analyzer.

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

Contract manufacturing;; input

Dates and Status

Sep 19, 2018

Sep 19, 2028