Taiwan FDA registration 351ef7e4e803c4ea300e3000006b3359

Innova PR-3 immunoglobulin G enzyme linked immunoassay reagent set

TW: 因諾瓦PR-3免疫球蛋白G酵素連結免疫分析法試劑組

Taiwan·Risk Class 2·INOVA DIANOSTICS, INC.·Registered Apr 21, 2006 – Apr 21, 2026Expired

Registration details

Analysis ID: 351ef7e4e803c4ea300e3000006b3359
Customs Code: DHA00601645103

Company information

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

Product details

Intended Use: Semi-quantitative detection of serine protease 3 (PR-3) antibody immunoglobulin G (IgG) in human serum samples was performed by Enzyme-Linked Immunoassay.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5660 多發性自體抗體免疫試驗系統
Import Information: import

Dates and status

Registration Date: Apr 21, 2006
Expiry Date: Apr 21, 2026

About this record

Access comprehensive regulatory information for Innova PR-3 immunoglobulin G enzyme linked immunoassay reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 351ef7e4e803c4ea300e3000006b3359 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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