This page includes the latest FDA filings for Immudex. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008559103 |
| FEI Number | 3008559103 |
| Name | IMMUDEX USA, LLC |
| Owner & Operator | Immudex |
| Contact Address | Symbion Fruebjergvej 3 Copenhagen DK-84 Region Hovedstaden 2100 DK |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 4031 University Dr Ste 100 Fairfax, VA 22030 US |
| Registration Number | 3008096179 |
| FEI Number | 3008096179 |
| Name | Stephen T Haley |
| Owner & Operator | Immudex |
| Contact Address | Symbion Fruebjergvej 3 Copenhagen DK-84 Region Hovedstaden 2100 DK |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 4031 University Dr Ste 100 Fairfax, VA 22030 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
Stephen T Haley [Immudex] | Dextramer? CMV Kit | 2017-10-25 |
Stephen T Haley [Immudex] | CMV Dextramer | 2013-12-07 |
Stephen T Haley [Immudex] | MHC Dextramer | 2012-06-19 |
Stephen T Haley [Immudex] | Dextramer | 2012-06-19 |