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QUANTA Flash SS-B Reagents - Taiwan Registration 053b689ee111d3b1341234c2425d9dac

Access comprehensive regulatory information for QUANTA Flash SS-B Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 053b689ee111d3b1341234c2425d9dac and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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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053b689ee111d3b1341234c2425d9dac
Registration Details
Taiwan FDA Registration: 053b689ee111d3b1341234c2425d9dac
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Device Details

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

Registration Details

053b689ee111d3b1341234c2425d9dac

Ministry of Health Medical Device Import No. 027881

DHA05602788106

Company Information

United States

Product Details

Combined with BIO-FLASH instrument for semi-quantitative antibodies against Schrรถgelian syndrome type B (SS-B) antigen in human serum by chemical cold light analysis.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Oct 15, 2015

Oct 15, 2025