Known Identifiers & Locations
FEI Numbers
3007662974
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 (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0006-2015 |
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500.
Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System.
Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Reason: Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
|
2014-08-11 |
Terminated
|
View Details
|
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