Rapid Sterility Instrument
Agency: Food and Drug Administration
Location: Irvine, California
NAICS: 334516
| Agency | Food and Drug Administration |
|---|---|
| Deadline | 03/26/26 |
| Posted | 03/20/26 |
| Estimated Value | Not Provided |
| Set Aside | None |
| NAICS | 334516 - Analytical Laboratory Instrument Manufacturing |
| PSC | 6640 - Laboratory Equipment And Supplies |
| Location | Irvine, CA USA |
Description This notice is issued for informational and market research purposes only and does not constitute a solicitation. The FDA intends to award a sole source Firm-Fixed-Price purchase order for one (1) Whole Genome Sequencing instrument. The Government is considering the Illumina MiSeq i100 System or equal product that meets all salient characteristics identified in the Statement of Work (SOW). Offerors proposing equal products shall demonstrate how the proposed product meets each of the salient characteristics The instrument shall include a minimum one (1) year manufacturer's warranty covering parts and labor.
Interested parties shall submit capability statements demonstrating ability to meet requirements. Offerors proposing an equivalent must clearly demonstrate how requirements are met.
March 26, 2026, at 2:30 PM ET Submission
Iris Johnson Email: Iris.Johnson1@fda.hhs.gov
Background The Food and Drug Administration (FDA), specifically the Irvine Medical Products Laboratory (IRVLMP), is responsible for performing microbiological testing on medical products to ensure compliance with USP and other regulatory requirements. To support sequencing of microorganisms obtained from regulatory pharmaceutical samples, the FDA intends to award a sole source Firm-Fixed-Price purchase order for one Whole Genome Sequencing instrument, specifically considering the Illumina MiSeq i100 System or an equivalent product that meets all salient characteristics identified in the Statement of Work (SOW). Work Details The Contractor shall provide one Whole Genome Sequencing instrument for IRVLMP, Irvine, CA, that meets or exceeds the following requirements: - 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 dimensions of 16” × 18” × 26” (W×D×H). Additionally, the Contractor shall provide a minimum one-year manufacturer’s warranty covering all parts, labor, and operational support, beginning upon final Government acceptance. Period of Performance Delivery shall occur within 60 days after award. Warranty begins upon acceptance. Place of Performance FDA / IRVLMP, 19701 Fairchild, Irvine, CA 92612
| Contact name | Iris Johnson |
|---|---|
| Contact email | iris.johnson1@fda.hhs.gov |
| Contact phone | (301) 796-3353 |
Agency: Food and Drug Administration
Location: Irvine, California
NAICS: 334516
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