Pure Global

QUANTA Lite RF IgM ELISA - Taiwan Registration b1308667b33e217848f47efe3ec575e6

Access comprehensive regulatory information for QUANTA Lite RF IgM ELISA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b1308667b33e217848f47efe3ec575e6 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.

Free Database
Powered by Pure Global AI
89,000+ Devices
b1308667b33e217848f47efe3ec575e6
Registration Details
Taiwan FDA Registration: b1308667b33e217848f47efe3ec575e6
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

QUANTA Lite RF IgM ELISA
TW: ๅ› ่ซพ็“ฆ้กž้ขจๆฟ•ๅ› ๅญๅ…็–ซ็ƒ่›‹็™ฝM้…ต็ด ้€ฃ็ตๅ…็–ซๅˆ†ๆžๆณ•ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

b1308667b33e217848f47efe3ec575e6

Ministry of Health Medical Device Import No. 028062

DHA05602806201

Company Information

United States

Product Details

This product uses Enzyme Linked Immunoassay to semi-quantitatively detect immunoglobulin M (IgM) rheumatoid factor (RF) antibodies in human serum samples.

C Immunology and microbiology devices

C5775 Rheumatoid factor immunoassay system

Imported from abroad

Dates and Status

Dec 29, 2015

Dec 29, 2025