Attachment B doc.pdf
PDF 155 KB Posted
- Attached to
- 6550--Immune Deficiency Reagents
- Solicitation number
- 36C26226Q0449
About this file
This is a Salient Characteristics attachment for a federal contract solicitation specifying requirements for Aquios CL reagents and supplies. The government requires reagents and supplies compatible with two existing Beckman Coulter Aquios CL flow cytometers (Serial Numbers BC38059 EE 114681 and BC38060 EE 114684) already in use in the clinical laboratory for VISN22. The product is ordered on an as-needed basis in individual unit quantities.
All proposed reagents must maintain 510K/IVD regulatory clearance when used according to manufacturer specifications and must be specifically compatible with the identified instrumentation and testing platform. Use of non-approved reagents or supplies will invalidate the IVD clearance of the test and result in cessation of testing for VISN22. Additionally, all reagents must be bar-coded and must conform to IVD usage requirements with the AQUIOS Flow Cytometer. The brand name specification is "Aquios CL Reagents and Supplies" with various product numbers available.
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Other files
| File | Type | Posted |
|---|---|---|
| RFQ doc.pdf | ||
| 36C26226Q0449.docx | DOCX document | |
| Attachment A.xlsx | XLSX spreadsheet |
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Text version
Attachment B – Salient Characteristics
Brand Name or Equal Description/Requirements:
Product Description Product # Unit of Issue Quantity Aquios CL Reagents and Supplies Various EA As needed
Salient Characteristics:
1. Must be compatible for use following equipment already in use in clinical laboratory:
a. Beckman Coulter Aquios CL (x2)
i. S/N BC38059 EE 114681
ii. S/N BC38060 EE 114684
2. This reagent testing is 510K/IVD cleared when used according to manufacturer specifications; any reagents not specifically compatible with this instrumentation/testing platform will invalidate the IVD clearance of the test. Invalidation due to use non-approved reagents or supplies will result in a cease of testing for VISN22.
3. BAR CODED and these bar coded reagents must conform to the IVD Usage with the AQUIOS Flow Cytometer.
File details come from the government source that posted it. Updated .