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Innova Sm enzyme-linked immunoassay test system - Taiwan Registration ba43facfbd6d801aeca4d4ad7defab91

Access comprehensive regulatory information for Innova Sm enzyme-linked immunoassay test system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ba43facfbd6d801aeca4d4ad7defab91 and manufactured by INOVA DIANOSTICS, 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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ba43facfbd6d801aeca4d4ad7defab91
Registration Details
Taiwan FDA Registration: ba43facfbd6d801aeca4d4ad7defab91
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Device Details

Innova Sm enzyme-linked immunoassay test system
TW: ๅ› ่ซพ็“ฆSm้…ต็ด ้€ฃ็ตๅ…็–ซๅˆ†ๆžๆณ•ๆชข้ฉ—็ณป็ตฑ
Risk Class 2

Registration Details

ba43facfbd6d801aeca4d4ad7defab91

DHA00601530401

Company Information

United States

Product Details

Enzyme Linked Immunoassay (ELISA) was used for semi-quantitative detection of Sm antibodies in human serological samples.

C Immunology and microbiology

C.5100 ๆŠ—ๆ ธๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

import

Dates and Status

Dec 07, 2005

Dec 07, 2025