Known Identifiers & Locations
FEI Numbers
2517506
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-0007-05 |
BC Thrombin Reagent . Thrombin Time Test
Reason: The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
|
2004-07-21 |
Terminated
|
View Details
|
| Z-0042-05 |
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Reason: APTT determinations when using affected rotors may lead to incorrectly shortened times
|
2004-08-27 |
Terminated
|
View Details
|
Profile Disclaimer
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