Taiwan FDA registration ba43facfbd6d801aeca4d4ad7defab91

Innova Sm enzyme-linked immunoassay test system

TW: 因諾瓦Sm酵素連結免疫分析法檢驗系統

Taiwan·Risk Class 2·INOVA DIANOSTICS, INC.·Registered Dec 07, 2005 – Dec 07, 2025Expired

Registration details

Analysis ID: ba43facfbd6d801aeca4d4ad7defab91
Customs Code: DHA00601530401

Company information

Manufacturer: INOVA DIANOSTICS, INC.
Manufacturer Country: United States
Authorized Representative: TRUGENE DIAGNOSTICS, INC.

Product details

Intended Use: Enzyme Linked Immunoassay (ELISA) was used for semi-quantitative detection of Sm antibodies in human serological samples.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5100 抗核抗體免疫試驗系統
Import Information: import

Dates and status

Registration Date: Dec 07, 2005
Expiry Date: Dec 07, 2025

About this record

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..

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