Taiwan FDA registration 6edd1f70864a78548608b9ab4f1e4595

Innova CCP immunoglobulin G enzyme linked immunoassay test system

TW: 因諾瓦 CCP 免疫球蛋白 G 酵素連結免疫分析法檢驗系統

Taiwan·Risk Class 2·INOVA DIANOSTICS, INC.·Registered Dec 30, 2005 – Dec 30, 2015Cancelled

Registration details

Analysis ID: 6edd1f70864a78548608b9ab4f1e4595
Customs Code: DHA00601513705

Company information

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

Product details

Intended Use: 利用免疫酵素法(Enzyme Linked Immunoassay, ELISA) 進行病患血清檢體內之抗 CCP (cyclic citrullinated peptide 環狀瓜氨酸胜?) 免疫球蛋白 G (IgG) 抗體之半定量檢測.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5775 類風濕性因子免疫試驗系統
Import Information: import

Dates and status

Registration Date: Dec 30, 2005
Expiry Date: Dec 30, 2015
Cancellation Date: Aug 09, 2018

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for Innova CCP immunoglobulin G 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 6edd1f70864a78548608b9ab4f1e4595 and manufactured by INOVA DIANOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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