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QUANTA Flash Ro60 Reagents - Taiwan Registration f13043b392643846ed075371e49b41b8

Access comprehensive regulatory information for QUANTA Flash Ro60 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f13043b392643846ed075371e49b41b8 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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f13043b392643846ed075371e49b41b8
Registration Details
Taiwan FDA Registration: f13043b392643846ed075371e49b41b8
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Device Details

QUANTA Flash Ro60 Reagents
TW: ๅ› ่ซพ็“ฆRo60ๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅๆ‡‰่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

f13043b392643846ed075371e49b41b8

Ministry of Health Medical Device Import No. 027717

DHA05602771706

Company Information

United States

Product Details

This product uses chemical cold light analysis to semi-quantitatively detect anti-Ro-60 autoimmune antibodies in human serum.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Oct 13, 2015

Oct 13, 2025