Envoy 500

Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

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.

Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide.

Envoy 500 Serum Control Kit. || The device is used for monitoring the performance of clinical chemistry methods within the clinical range.