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Apex thyroid-stimulating hormone receptor antibody test set - Taiwan Registration 9542f96c5469ae0ec1fb55025afcb861

Access comprehensive regulatory information for Apex thyroid-stimulating hormone receptor antibody 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 9542f96c5469ae0ec1fb55025afcb861 and manufactured by DENKA CO., LTD;; Abbott Ireland Diagnostics Division. 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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9542f96c5469ae0ec1fb55025afcb861
Registration Details
Taiwan FDA Registration: 9542f96c5469ae0ec1fb55025afcb861
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Device Details

Apex thyroid-stimulating hormone receptor antibody test set
TW: ไบžๅŸน็”ฒ็‹€่…บๅˆบๆฟ€็ด ๅ—้ซ”ๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

9542f96c5469ae0ec1fb55025afcb861

DHA05603616701

Product Details

This product is used to quantitatively detect thyroid-stimulating hormone receptor antibodies (TRAb) in human serum by chemical cold light particle immunoassay (CMIA) on the Alinity i System

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

C.5870 Cypress of the Upper Gland; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products

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Dates and Status

May 02, 2023

May 02, 2028