SOW doc.pdf

This is a Salient Characteristics attachment from a federal contract solicitation for Aquios CL Reagents and Supplies. The government requires various reagent and supply products for use with existing Beckman Coulter Aquios CL flow cytometry equipment, specifically two instruments with serial numbers BC38059 EE 114681 and BC38060 EE 114684. The unit of issue is each (EA), and quantities are specified as "as needed," indicating this is likely a requirements or blanket purchase agreement type contract.

The salient characteristics establish strict compatibility and regulatory requirements. All reagents must be compatible with the identified Beckman Coulter Aquios CL equipment and must maintain 510K/IVD clearance when used according to manufacturer specifications. Non-approved reagents or supplies that invalidate the IVD clearance will result in cessation of testing for VISN22. Additionally, all reagents must be bar-coded and conform to IVD Usage standards for the AQUIOS Flow Cytometer. These requirements ensure regulatory compliance and operational continuity for the clinical laboratory's flow cytometry testing operations.