Microgenics Corporation

Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.

Thermo Scientific QMS Everolimus Assay; || Model number: || 0380000 (US Distribution); || 0373852 (Foreign Distribution) || Product Usage: || The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.

Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.

DRI Salicylate Serum Tox Assay, Catalog number 0977. || Toxicology: || The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.