BVBLUE
Test, Vaginal, Bacterial Sialidase
GRYPHUS DIAGNOSTICS, L.L.C.
The following data is part of a premarket notification filed by Gryphus Diagnostics, L.l.c. with the FDA for Bvblue.
Pre-market Notification Details
| Device ID | K993732 |
| 510k Number | K993732 |
| Device Name: | BVBLUE |
| Classification | Test, Vaginal, Bacterial Sialidase |
| Applicant | GRYPHUS DIAGNOSTICS, L.L.C. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris GRYPHUS DIAGNOSTICS, L.L.C. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Product Code | MXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-04 |
| Decision Date | 2000-05-15 |
| Summary: | summary |
Trademark Results [BVBLUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BVBLUE 85786705 4383224 Live/Registered |
Gryphus Diagnostics, L.L.C. 2012-11-26 |
 BVBLUE 75661232 2324258 Dead/Cancelled |
Gryphus Diagnostics, L.L.C. 1999-03-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.