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QUANTA Flash ENA7 Reagents - Taiwan Registration e970a514d4469c93c2e18192a35be8e8

Access comprehensive regulatory information for QUANTA Flash ENA7 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e970a514d4469c93c2e18192a35be8e8 and manufactured by INOVA Diagnostics, Inc. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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e970a514d4469c93c2e18192a35be8e8
Registration Details
Taiwan FDA Registration: e970a514d4469c93c2e18192a35be8e8
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Device Details

QUANTA Flash ENA7 Reagents
TW: ๅ› ่ซพ็“ฆ7้ …ๆŠ—ๆ ธๆŠ—้ซ”ๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅๆ‡‰่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

e970a514d4469c93c2e18192a35be8e8

Ministry of Health Medical Device Import No. 032465

DHA05603246502

Company Information

United States

Product Details

This product is equipped with Bio-Flash instrument to qualitatively monitor IgG antibodies against Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum by chemical cold light immunoassay.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Jul 12, 2019

Jul 12, 2024