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QUANTA Flash dsDNA Reagents - Taiwan Registration cb191a78af68e30cef0b3527b9fd9e7e

Access comprehensive regulatory information for QUANTA Flash dsDNA Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cb191a78af68e30cef0b3527b9fd9e7e and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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cb191a78af68e30cef0b3527b9fd9e7e
Registration Details
Taiwan FDA Registration: cb191a78af68e30cef0b3527b9fd9e7e
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Device Details

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

Registration Details

cb191a78af68e30cef0b3527b9fd9e7e

Ministry of Health Medical Device Import No. 028447

DHA05602844708

Company Information

United States

Product Details

This product quantifies anti-dsDNA antibodies in human serum by chemical cold light analysis. Combining other test results with clinical symptoms can help diagnose systemic lupus erythematosus.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Jun 21, 2016

Jun 21, 2026