QUANTA Flash ENA7 Reagents - Taiwan Registration e970a514d4469c93c2e18192a35be8e8
Access comprehensive regulatory information for QUANTA Flash ENA7 Reagents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e970a514d4469c93c2e18192a35be8e8 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.
Device Details
Registration Details
e970a514d4469c93c2e18192a35be8e8
Ministry of Health Medical Device Import No. 032465
DHA05603246502
Product Details
This product is equipped with Bio-Flash instrument to qualitatively monitor IgG antibodies against Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum by chemical cold light immunoassay.
C Immunology and microbiology devices
C5100 Antinuclear antibody immunoassay system
Imported from abroad
Dates and Status
Jul 12, 2019
Jul 12, 2024

