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Apei Cell Keratin 21-1 Test Reagent Set - Taiwan Registration 98e59f43e1edd4e109dfaac44f82985c

Access comprehensive regulatory information for Apei Cell Keratin 21-1 Test Reagent Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 98e59f43e1edd4e109dfaac44f82985c 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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98e59f43e1edd4e109dfaac44f82985c
Registration Details
Taiwan FDA Registration: 98e59f43e1edd4e109dfaac44f82985c
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Device Details

Apei Cell Keratin 21-1 Test Reagent Set
TW: ไบžๅŸน็ดฐ่ƒž่ง’่ณช่›‹็™ฝ21-1ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

98e59f43e1edd4e109dfaac44f82985c

DHA05603247005

Company Information

Product Details

ๆœฌ็”ขๅ“็”จๆ–ผAlinity i ๅˆ†ๆžๅ„€ไธŠ,ไปฅๅŒ–ๅญธๅ†ทๅ…‰ๅพฎ็ฒ’ๅ…็–ซๅˆ†ๆžๆณ•(chemiluminescent microparticle immunoassay;CMIA)ๅฎš้‡ๆชขๆธฌไบบ้กž่ก€ๆธ…ๅŠ่ก€ๆผฟไธญ็š„็ดฐ่ƒž่ง’่ณช่›‹็™ฝ็‰‡ๆฎต19.

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

Input;; Contract manufacturing

Dates and Status

Aug 02, 2019

Aug 02, 2029