Known Identifiers & Locations
FEI Numbers
3017344
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0011-2008 |
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML
Microbiological media plates
Reason: Marketed a regulated product without a 510(k).
|
2007-08-17 |
Terminated
|
View Details
|
| Z-0014-2008 |
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA
Catalog #P1174
Reason: Plates manufactured without vancomycin. Possibility for false resistant results.
|
2007-04-23 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.