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QUANTA Flash Ro52 Reagents - Taiwan Registration aaf34ce97bcc4d459cfb866e846a3c17

Access comprehensive regulatory information for QUANTA Flash Ro52 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number aaf34ce97bcc4d459cfb866e846a3c17 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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aaf34ce97bcc4d459cfb866e846a3c17
Registration Details
Taiwan FDA Registration: aaf34ce97bcc4d459cfb866e846a3c17
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Device Details

QUANTA Flash Ro52 Reagents
TW: ๅ› ่ซพ็“ฆRo52ๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅๆ‡‰่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

aaf34ce97bcc4d459cfb866e846a3c17

Ministry of Health Medical Device Import No. 028109

DHA05602810901

Company Information

United States

Product Details

This product uses chemical cold light analysis to semi-quantify anti-Ro52 autoimmune antibodies in human serum.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Mar 03, 2016

Mar 03, 2026