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QUANTA Flash Scl-70 Reagents - Taiwan Registration d00fb5f05a6453c66ee150ae4e280a55

Access comprehensive regulatory information for QUANTA Flash Scl-70 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d00fb5f05a6453c66ee150ae4e280a55 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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d00fb5f05a6453c66ee150ae4e280a55
Registration Details
Taiwan FDA Registration: d00fb5f05a6453c66ee150ae4e280a55
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Device Details

QUANTA Flash Scl-70 Reagents
TW: ๅ› ่ซพ็“ฆScl-70ๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅๆ‡‰่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

d00fb5f05a6453c66ee150ae4e280a55

Ministry of Health Medical Device Import No. 028955

DHA05602895501

Company Information

United States

Product Details

This product uses chemical cold light analysis to semi-quantify anti-Scl-70 autoimmune antibody in human serum.

C Immunology and microbiology devices

C5100 Antinuclear antibody immunoassay system

Imported from abroad

Dates and Status

Nov 18, 2016

Nov 18, 2026