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QUANTA Flash Sm Controls - Taiwan Registration fa925deaa5de7606c3bbecc78109acbc

Access comprehensive regulatory information for QUANTA Flash Sm Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fa925deaa5de7606c3bbecc78109acbc and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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fa925deaa5de7606c3bbecc78109acbc
Registration Details
Taiwan FDA Registration: fa925deaa5de7606c3bbecc78109acbc
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Device Details

QUANTA Flash Sm Controls
TW: ๅ› ่ซพ็“ฆSmๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅฐ็…ง็ต„
Risk Class 2
MD

Registration Details

fa925deaa5de7606c3bbecc78109acbc

Ministry of Health Medical Device Import No. 027083

DHA05602708304

Company Information

United States

Product Details

This product is used in QUANTA Flash Sm chemical cold light immunoassay for semi-quantitative detection and analysis of Sm antibodies in human serum samples.

A Clinical chemistry and clinical toxicology

A1660 Quality Control Materials (Analytical and Non-Analytical)

Imported from abroad

Dates and Status

Mar 03, 2015

Mar 03, 2025