A02-MEC- In_Vitro_Diagnostic_Laboratory_Instruments.pdf
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- Attached to
- In Vitro Diagnostic Laboratory Instruments
- Solicitation number
- HT942626QE048
- Issued by
- Not on record
About this file
This document is a Minimum Essential Characteristics (MEC) specification for the procurement of in vitro diagnostic laboratory instruments. The requirement specifies the delivery of three QuantStudio 7 Pro Dx Real-Time PCR Systems (Model A51192) with all necessary sub-components and software. The instruments must comply with U.S. Food and Drug Administration In Vitro Diagnostic (US-IVD) standards and the European In Vitro Medical Devices Regulation (EU 2017/746) (IVDR). Each system must include Diomni Software for Diomni Enterprise IVD (A58195), and the contractor must provide a one-year warranty covering spare parts, repairs, labor, travel, customer support, and product orientation.
Delivery and installation services must be completed at 508 Research Drive, Building 508, Silver Spring, Maryland 20910. The contractor is responsible for delivering and assembling the instruments, installing necessary software and firmware updates, performing calibration and function testing, and providing user-level training on operation and maintenance to all designated laboratory personnel as identified by the Contracting Officer's Representative (COR). The contractor must also uninstall and remove three existing QuantStudio instruments (Model numbers 287880802, 287880906, and 287880902) and provide a trade-in allowance toward the cost of the new instruments.
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| File | Type | Posted |
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| Solicitation - HT942626QE048.pdf |
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CUI//PROCURE
CUI//PROCURE
Minimum Essential Characteristics (MEC)
In Vitro Diagnostic Laboratory Instruments
Materiel Requirements:
• Instrument: QuantStudio 7 Pro Dx Real-Time PCR System (A51192)
• Quantity: Three, to include all necessary sub-components and software o Instruments shall be U.S. Food and Drug Administration In Vitro Diagnostic (US-IVD) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR) compliant.
o Diomni Software for Diomni Enterprise IVD (A58195), quantity three.
o Provide one-year warranty to include spare parts, repairs, labor, travel, customer support, and product orientation.
Delivery and Installation:
• Address: 508 Research Drive, Bldg 508, Silver Spring, MD 20910
• Deliver and assemble as necessary. Install necessary software and firmware updates. Perform calibration and function tests.
• Provide user level training of operation. Provide user level training on maintenance. Audience for this training shall be all designated laboratory personnel as provided by the Contracting Officer’s Representative (COR).
Removal and Trade-in of Current Instruments:
• Uninstall and remove current QuantStudio instruments (287880802, 287880906, and 287880902).
• Provide trade-in allowance toward the procurement of the new instruments.
File details come from the government source that posted it. Updated .