SOW_OC-2026-132529.pdf
PDF 113 KB Posted
- Attached to
- Illumina MiSeq i100 System or equal
- Solicitation number
- NOI_OC-2026-132529
About this file
This is a Statement of Work for the purchase of one Whole Genome Sequencing instrument for the FDA's Irvine Medical Products Laboratory (IRVLMP) in Irvine, California. The instrument will support microbiological testing and sequencing of microorganisms obtained from regulatory pharmaceutical samples to ensure compliance with USP and other regulatory requirements.
The contractor must provide an Illumina MiSeq i100 System or an equivalent whole genome sequencing instrument capable of supporting existing validated laboratory workflows. The system must utilize sequencing-by-synthesis next-generation sequencing technology and support single-read and paired-end libraries with specifications including output up to 25 Gigabases, up to 200 million paired-end reads per run, maximum read length of at least 2 × 500 base pairs, ≥85% of bases achieving Q30 at 2 × 300bp, RFID or equivalent consumable tracking, room-temperature reagent storage, onboard data collection and sequence alignment software, monitor and control computer, and benchtop dimensions not exceeding 16" × 18" × 26" (W×D×H). The instrument must be delivered within 60 days of award to FDA/IRVLMP at 19701 Fairchild, Irvine, CA 92612. The contractor shall provide a minimum one-year manufacturer's warranty covering all parts, labor, and operational support beginning upon final government acceptance, and shall submit service reports for any warranty-related service performed including equipment identification, issue description, corrective action taken, parts replaced, and technician information.
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STATEMENT OF WORK
Purchase of One (1) Whole Genome Sequencing Instrument for IRVLMP
Background The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), performs microbiological testing on medical products to ensure compliance with USP and other regulatory requirements. A Whole Genome Sequencing instrument is required to support sequencing of microorganisms obtained from regulatory pharmaceutical samples.
Scope The Contractor shall provide one (1) Whole Genome Sequencing instrument for IRVLMP, Irvine, CA, that meets or exceeds the requirements below.
Requirements
• The Contractor shall provide an Illumina MiSeq i100 System or an equivalent
Whole Genome Sequencing instrument capable of supporting existing validated laboratory workflows.
• Uses sequencing-by-synthesis next-generation sequencing technology
• Supports single-read and paired-end libraries
• Output range up to 25 Gigabases
• Up to 200 million paired-end reads per run
• Maximum read length of at least 2 × 500 base pairs
• ≥85% of bases achieving Q30 at 2 × 300bp
• RFID or equivalent consumable tracking
• Reagents stored at room temperature
• Includes onboard data collection and sequence alignment software
• Includes monitor and control computer
• Benchtop system not exceeding 16” × 18” × 26” (W×D×H)
Warranty Requirement The Contractor shall provide a minimum one (1) year manufacturer’s warranty covering all parts, labor, and operational support. Warranty shall begin upon final Government acceptance.
Records and Reports For any warranty-related service performed, the Contractor shall provide a service report including equipment identification, description of issue and corrective action, parts replaced, and technician information.
Deliverables / Delivery Schedule Deliverable Quantity Due Date
Whole Genome Sequencing System
1 Within 60 days after award
Manufacturer Warranty 1 Begins upon acceptance
Delivery Location
FDA / IRVLMP
19701 Fairchild Irvine, CA 92612
Period of Performance Delivery shall occur within 60 days of award. Warranty begins upon acceptance.
| Warranty Requirement |
| Records and Reports |
| Deliverables / Delivery Schedule |
| Delivery Location |
| Period of Performance |
File details come from the government source that posted it. Updated .