This page includes the latest FDA filings for Opko Health Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| USA | NASDAQ | OPK | DUNS 783980345 |
| Registration Number | 3010909452 |
| FEI Number | 3010909452 |
| Name | OPKO Diagnostics, LLC |
| Owner & Operator | OPKO Health, Inc. |
| Contact Address | 4400 Biscayne Boulevard Miami FL 33137 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 4 Constitution Way Suite F Woburn, MA 01801 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| OPKO Health, Inc. | 4Kscore Test | 2021-12-07 |
OPKO Diagnostics, LLC [OPKO Health, Inc.] | Sangia Total PSA Test | 2019-02-19 |
OPKO HEALTH, INC. | SPECTRAL OCT/SLO | 2008-11-14 |
| NCAGE Code | 5KMH6 | OPKO HEALTH, INC. |
| CAGE Code | 5KMH6 | OPKO HEALTH, INC. |
| S.A.M. Registration | 5KMH6 [783980345] | OPKO HEALTH, INC. |
| SEC | 0000944809 | Opko Health, Inc. of DELAWARE |