This page includes the latest FDA filings for Genova Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Genova Diagnostics holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 1055886 |
| FEI Number | 1000111208 |
| Name | Genova Diagnostics |
| Owner & Operator | GENOVA DIAGNOSTICS |
| Contact Address | 63 ZILLICOA ST. -- Asheville NC 28801 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 63 Zillicoa St Asheville, NC 28801 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
GENOVA DIAGNOSTICS | PHICAL TEST | 2006-04-26 |
Genova Diagnostics | INTESTINAL PERMEABILITY TEST SYSTE | 1993-12-10 |
Genova Diagnostics | GREAT SMOKIES DIAGNOSTIC LABORATORY | 1993-12-10 |