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Cue Health Inc. San Diego CA 92121 USA

UEI: SLED_987D037B95253BF2

Cue Health Inc. San Diego CA 92121 USA is a federal contractor, registered under UEI SLED_987D037B95253BF2. It has been awarded $28,430,768 across 1 federal contract. Primary work spans In-Vitro Diagnostic Substance Manufacturing. Top awarding agencies include Barda - Aspr / Daappo / Barda Dcma.

Contact Information

Registration and classification details

Registration

UEI Code

SLED_987D037B95253BF2

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

Key Performance Metrics

Awards Count

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Award Analytics & Distribution

Awards by Agency

Barda - Aspr / Daappo / Barda Dcma$28.4M100%

Awards by NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing$28.4M100%

Awards by Agency Over Time

Awards by Place of Performance

Open opportunities in Cue Health Inc. San Diego CA 92121 USA's top NAICS codes and agencies

CONTROL, RESPIRATORY PA

Solicitation # SPE2DS-26-T-311F

The BioFire RP2.1/RP2.1plus Control Panel is a synthetic nucleic acid-based quality control product consisting of 12 vials, each containing 300 microliters of a non-infectious buffer solution with stabilizers and preservatives. It is designed for in vitro use with the FilmArray instrument to monitor the detection and identification of respiratory pathogens during RP2.1 panel testing. Each kit provides sufficient reagent for six quality control runs, including six positive and six negative controls. The product requires strict frozenstorage between -25°C and -15°C (-13°F to 5°F) and has a non-extendable shelf life of 18 months, with no more than two months allowed to have passed from the date of manufacture to delivery to the government. Labeling must include the date of manufacture, expiration date, contract number, and lot number in compliance with Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must meet commercial standards, ensuring protection against damage, with exterior containers suitable for safe transport at the lowest cost to the specified delivery point. The item is governed by DLA technical and packaging requirements, including RS013 for shelf life, RP001 for packaging standards, and RD003 for potential covered defense information. The National Stock Number is 6550-01-690-4435, with a procurement quantity of three kits under solicitation SPE2DS-26-T-311F, with a delivery deadline of 83 days after award.

MEDICAL SUPPLY CHAIN MD SURG FSF

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TEST KIT, CORONAVIRUS D

Solicitation # SPE2DS-26-T-308W

The contract is for the procurement of 150,000 units of the QuickVue At-Home OTC COVID-19 Test kit, a rapid antigen detection system designed for self-administration using an anterior nasal swab. Each kit contains all necessary components for two tests, including a tube holder, two prefilled extraction tubes, two swabs, and two test strips with a dipstick format that delivers results in ten minutes through a two-color readout: a blue control line and a red test line. The test is intended for single-user administration, with the two tests in each kit to be performed 24 to 36 hours apart, eliminating the need for additional equipment or laboratory support. Built-in procedural controls ensure test validity, and all materials are pre-assembled for immediate use. The kits are to be delivered within 20 days of award under solicitation SPE2DS-26-T-308W, issued by the Department of Defense’s Medical Supply Chain MD Surg FSF, with performance specified to occur in West Los Angeles, CA. The contract includes adherence to DLA technical and quality requirements under RA001, packaging standards per RP001, and removal protocols for government identification on non-accepted items per RQ011, with the NSN 6550-01-697-6662 identifying the product for federal acquisition purposes.

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CONTROL SET, GLUCOSE

Solicitation # SPE2DS-26-T-308J

The control set for glucose is designed for use with the Accu-Chek Inform II system and includes two 2.5 mL vials—one each of Level 1 and Level 2 control solutions—to ensure accurate calibration and performance verification of test strips. It must be stored between 39 and 86 degrees Fahrenheit (4 to 30 degrees Celsius) and must not be frozen. The item is issued as a single unit and is subject to strict medical procurement standards, including commercial packaging requirements that ensure protection from damage and safe delivery by common carriers. All units must be marked in accordance with Medical Marking Standard No. 1, which supersedes MIL-STD-129, and include the date of manufacture, expiration or retest date, contract number, and lot number. The item has a non-extendable shelf life of 24 months, and no more than three months may have elapsed from the date of manufacture to the date of government delivery. Technical and quality requirements referenced under R and I numbers are governed by the DLA Master List, with revision standards tied to solicitation or award dates depending on acquisition size. This item is classified as a Type I (Code M) medical supply, and all labeling, packaging, and marking must comply with the latest version of MMS1C. The NSN is 6550-01-642-5011, the solicitation number is SPE2DS-26-T-308J, and delivery is required within 20 days after order award to Fort Campbell, with the contract managed by the Department of Defense under the Medical Supply Chain.

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Fisher Scientific Reagents and Consumable Materials for Cell Therapy Manufacturing

Solicitation # 26-008155

The National Institutes of Health Clinical Center plans to award a sole-source firm-fixed-price purchase order to Fisher Scientific for validated reagents and consumable materials essential to the manufacturing of FDA-regulated cell-based therapies used in NIH clinical trials. These materials have been rigorously validated and approved by the Center for Cellular Engineering’s Quality Assurance Department to ensure consistent quality, safety, and efficacy in producing cell therapies for patient care. Any substitution of these materials would necessitate extensive and costly revalidation of manufacturing processes, leading to significant delays and potential risks to ongoing clinical trials, making Fisher Scientific the only viable supplier capable of providing the required validated products and supporting documentation compliant with federal regulatory standards. The acquisition is authorized under FAR 13.106-1(b)(1)(i), which allows for single-source procurement when only one provider can meet the government’s specific requirements, and the value does not exceed the simplified acquisition threshold. The product service code is 6550, and the NAICS code is 325413, classifying the items as in-vitro diagnostic substances. Performance will occur at the NIH Clinical Center in Bethesda, Maryland. While this notice does not solicit bids or proposals, responsible parties may submit capability statements by August 13, 2026, at 6:00 p.m. Eastern Time, referencing POTS 26-008155, though the government retains full discretion to proceed without competition. All inquiries should be directed to Shasheshe Goolsby of the Hospital and Laboratory Support Division.

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CryoStor® CS10, 100 mL Bags for Cell Therapy Manufacturing

Solicitation # 26-007655

The National Institutes of Health Clinical Center plans to award a sole-source firm-fixed-price purchase order to BioLife Solutions for 80 bags of CryoStor® CS10, 100 mL, used exclusively for cryopreserving cell therapy products in FDA-regulated clinical trials. The product is essential to the Center for Cellular Engineering’s manufacturing processes, having been rigorously validated and approved by quality assurance to ensure the safety and consistency of therapies administered to patients. Substituting an alternative cryoprotectant would necessitate extensive revalidation, leading to significant delays, increased costs, and potential disruption to patient care. CryoStor® CS10 is the only commercial cryoprotectant with an FDA Master File and is the only product fully qualified for use in the NIH’s regulated environment, justifying the sole-source designation under FAR 13.106-1(b)(1)(i). The acquisition supports critical clinical research operations at the NIH Clinical Center in Bethesda, Maryland, under PSC 6550 and NAICS 325413. While the notice does not request formal proposals, responsible parties may submit capability statements by August 13, 2026, though the government reserves the right to proceed without competition. All submissions must reference solicitation number 26-007655 and be sent electronically to Shasheshe Goolsby at the NIH Office of Acquisitions and Logistics Management.

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CHIP, HYDROGEN PEROX

Solicitation # SPE2DS-26-T-300S

The contract under solicitation SPE2DS-26-T-300S is for the procurement of one unit of CHIP, HYDROGEN PEROXIDE for use with a CMS analyzer, featuring ten measurement capillaries filled with a substance-specific reagent detection system calibrated to a measuring range of 0.20–2.0 ppm and capable of conducting ten tests. The procurement is managed by the Defense Logistics Agency under the Department of Defense, with a response deadline of August 10, 2026, and a posted date of August 3, 2026. Delivery is required at Camp Carroll, Waegwan, Korea, under FOB Destination terms, with the item to be delivered within 84 calendar days of the request issue date, resulting in an anticipated delivery window ending around October 27, 2026. The contract specifies a fixed-price structure with no option quantities indicated, and while individual unit pricing is listed at $122.00, the total contract value cannot be determined due to incomplete pricing details. Compliance with stringent packaging and marking standards is mandatory, governed by MIL-STD-2073-1E and the Medical Marking Standard No. 1, which supersedes MIL-STD-129 for medical items. Labels must include the date of manufacture, expiration or retest date, contract number, and lot number, with hazardous material labeling adhering to the Hazard Communication Standard and specific submission requirements for hazard warning labels and material safety data sheets prior to award. The contractor must use Wide Area WorkFlow for electronic invoicing and receiving reports, and the government conducts all inspection and acceptance at the delivery point. Numerous FAR and DFARS clauses are incorporated, including those on employment eligibility verification, combating human trafficking, sustainable products, safeguarding contractor information systems, and NIST SP 800-171 compliance, some with deviations allowing for modified application. Offerors must hold a valid Unique Entity ID and CAGE code, submit socioeconomic status representations, and disclose any covered defense telecommunications equipment or joint venture partnerships. All proposals must be submitted electronically via DIBBS, and no physical attachments or formal evaluation factors are specified beyond implicit Low Price Technically Acceptable considerations typical of simplified acquisitions.

Defense Logistics Agency

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KIT, PERFORMANCE QUALIF

Solicitation # SPE2DS-26-T-296S

The contract is for the procurement of a single performance qualification kit for electrochemiluminescence (ECL) testing, specifically designed for use with the MSD PR2 Model 1800 instrument. Each kit includes ten plates and corresponding reagents and is classified as a Type I, Code H item with a strict 12-month non-extendable shelf life. The item is regulated by the FDA and must be supplied with full manufacturer and part number disclosure for verification by the contracting officer. Packaging and labeling must strictly follow Medical Marking Standard No. 1, which replaces all references to MIL-STD-129 for medical acquisitions, and all units must be sealed in commercial-grade containers that prevent damage and breakage during transport. Packaging must comply with MIL-STD-2073-1E, and palletization must adhere to DLA Packaging Requirements for Procurement (RP001). The delivery is FOB destination, with the primary delivery location at APO AP 96278-2060 and an alternative freight address at Osan Air Base, South Korea. The item must be delivered within 20 days of solicitation issuance, with an original required delivery date of August 4, 2026, and no quantity variance is permitted. Payment must be processed through Wide Area WorkFlow, and electronic submission of receiving reports is mandatory. The contract incorporates multiple FAR and DFARS clauses related to cybersecurity, safeguarding covered defense information, prohibition of certain foreign telecommunications equipment, hazardous material handling, subcontracting, inspection at destination, and compliance with whistleblower and compensation reporting requirements. Offerors must possess and provide a Unique Entity Identifier (UEI) and CAGE code and are required to represent their size status and socioeconomic certifications, though no such disclosures are completed in the solicitation. All technical and quality requirements referenced are drawn from the DLA Master List of Technical and Quality Requirements, and the contract remains subject to all applicable defense regulations and compliance standards.

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TEST KIT, CORONAVIRUS D

Solicitation # SPE2DS-26-T-296T

The contract specifies the procurement of Abbott BinaxNOW COVID-19 Antigen Self Tests for over-the-counter, at-home use, with a total quantity of five cases, each containing twelve kits and two tests per kit. Each kit must be stored between 2 and 30 degrees Celsius and must have a shelf life of exactly twelve months from the date of manufacture, with no extension permitted. No more than one month may have passed between the date of manufacture and the date of delivery to the government. All packaging must conform to commercial standards and the Medical Marking Standard No. 1, replacing all prior references to MIL-STD-129. Labels on every unit must clearly display the date of manufacture, expiration or retest date, and the contract or lot number. The items must be packed in sealed unit containers that protect against damage and shipped in suitable exterior containers to ensure safe, cost-effective delivery to the designated FPO address. Technical and quality requirements referenced in the DLA Master Listapply, and the procurement is subject to defense information handling protocols. The contract was issued under solicitation SPE2DS-26-T-296T with a response deadline of August 10, 2026, and requires delivery within twenty days of award.

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CONTROL, GLUCOSE

Solicitation # SPE2DS-26-T-295F

The contract specifies the procurement of 8 units of Prodigy Blood Glucose Control Solution High Level 2, a medical solution designed to ensure accurate blood glucose testing with Prodigy monitoring systems. Each unit contains 4 milliliters of solution and must meet strict technical and quality standards outlined in the DLA Master List of Technical and Quality Requirements, including compliance with packaging, labeling, and marking regulations per Medical Marking Standard No. 1, which supersedes MIL-STD-129. The product must be packaged in sealed unit containers and shipped in commercial exterior containers suitable for safe delivery via common carrier at the lowest rate to Fort Hood, Texas, with all labeling including the date of manufacture, expiration date, contract number, and lot number in accordance with MMS1C. The item is classified as a TYPE I (CODE M) with a non-extendable shelf life of 24 months; no more than four months may have elapsed from the date of manufacture to the date of government delivery. Storage requirements mandate temperatures between 36° and 86° Fahrenheit (2° to 30° Celsius) with no freezing. The solicitation, issued under SPE2DS-26-T-295F, requires bidders to clearly specify the source and part number of the supplied goods, with a response deadline of August 10, 2026, and delivery expected within 20 days after award. The procurement is managed by the Department of Defense’s Medical Supply Chain, with Mary-Kathryn Donahue as the primary point of contact.

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CONTROL, BLOOD CHEMI

Solicitation # SPE2DS-26-T-297Y

This contract specifies the procurement of CONTROL, BLOOD CHEMISTRY reagent Level 2, intended for use with the i-STAT PT PLUS cartridge on the i-STAT 1 blood gas analyzer, primarily for coagulation testing. The product is supplied in a box of ten 1.0 mL units and must comply with strict technical and packaging standards, including adherence to Medical Marking Standard No. 1, which replaces MIL-STD-129. The item requires refrigerated storage between 2°C and 8°C (36°F to 46°F) and must not be frozen. The reagent has a non-extendable shelf life of 12 months, with no more than one month allowed to have elapsed from the date of manufacture to the date of government delivery. All packaging must include clear labeling of the date of manufacture, expiration or retest date, contract number, and lot number, in accordance with the latest revision of MMS1C. Packaging must meet commercial standards to ensure safe transport by common carrier at the lowest cost, and all items must be properly sealed and protected from damage. The solicitation number is SPE2DS-26-T-297Y, with a response deadline of August 10, 2026, and delivery must occur within five days of award. The NSN is 6550-01-725-6872, and bidders must clearly identify the source and part number of the supplied item.

MEDICAL SUPPLY CHAIN MD SURG FSF

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Presolicitation Notice - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response

Solicitation # 75A50126R00001_RFP_PreSolNotice_NPIVS-2027

The U.S. Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is seeking qualified contractors to support the ongoing Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. Contractors must be capable of furnishing all necessary services, personnel, equipment, materials, and U.S.-based facilities to produce vaccines, antigens, and adjuvants for pandemic influenza and other viruses with pandemic potential. To be eligible, offerors must either hold an active U.S. influenza vaccine license from the FDA or have submitted a Biologics License Application for a seasonal or pandemic influenza vaccine. The program demands the generation and submission of comprehensive regulatory data—including analytical, nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) information—to the FDA to enable rapid decision-making and maintain manufacturing readiness during interpandemic periods. The anticipated contract is an indefinite delivery, indefinite quantity (IDIQ) vehicle with a base performance period of 60 months and the potential to extend up to 120 months if all option periods are exercised, combining both cost-reimbursement and firm-fixed-price task orders. Performance is expected to occur primarily within the United States, with the place of performance designated as Washington, D.C., and the contracting office located at 400 7th Street SW. Proposals must be submitted electronically via SAM.gov by the deadline of August 15, 2026, and are subject to evaluation based on mandatory qualification requirements, with full evaluation factors and source selection criteria expected to be detailed in the forthcoming Request for Proposals. The solicitation number is 75A50126R00001, and the NAICS code is 541714 for research and development in biotechnology. The primary point of contact for inquiries is Laura Saddison, BARDA Contracting Officer, reachable at Laura.Saddison@hhs.gov. No set-aside is planned, and full and open competition is anticipated. While packaging, marking, inspection procedures, and specific invoicing methods are not defined in this presolicitation, contractors should prepare to comply with FDA regulatory standards and anticipate the use of federal systems such as WAWF for payment processing. No contracting officer’s representative or technical representative has been designated yet, and all certifications and representations will be required upon formal proposal submission.

Barda - Aspr / Daappo / Barda Dcma

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Cold Chain Logistics and Vaccine Distribution PlanningThe contract seeks the development and validation of cold chain distribution plans specifically tailored for the rapid deployment of pandemic influenza vaccines, with a strong emphasis on packaging integrity and transport reliability under real-world conditions. The work requires designing scalable logistics frameworks that ensure vaccine stability from manufacturing through final delivery, accounting for temperature-sensitive handling, transit time constraints, and geographic variability in distribution networks. Validation protocols must rigorously test performance under stress conditions to confirm compliance with regulatory and safety standards, ensuring vaccines remain potent and viable throughout the supply chain. Deliverables will include documented distribution strategies, validated packaging systems, and tested transport methodologies suitable for immediate activation during a public health emergency. The performance location is Washington, DC, with a 20024 zip code, indicating direct alignment with federal health infrastructure. Subcontractors must respond by August 15, 2026, and the work falls under NAICS code 484220 for specialized freight trucking, reflecting the focus on secure, time-sensitive medical logistics. The contracting entity is the Department of Health and Human Services under Barda-ASPR/DAAPO, underscoring the national preparedness imperative behind this effort.

Barda - Aspr / Daappo / Barda Dcma

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Pandemic Influenza Surveillance and Strain Selection SupportThe contract seeks to establish a subcontract for comprehensive global surveillance and analysis supporting the selection of pandemic influenza strains, with a focus on antigenic characterization and bioinformatics capabilities. The work involves monitoring influenza viruses worldwide to assess their antigenic properties, genetic evolution, and potential pandemic risk, enabling informed decisions for vaccine development and public health preparedness. Data collection and analysis must be conducted at a global scale, ensuring timely, accurate, and actionable insights for government health authorities. The performance location is in Washington, D.C., with a federal oversight entity under the Department of Health and Human Services, specifically Barda – ASPR/DAAPPO/Barda DCMA. The contract is categorized under NAICS code 541690, indicating it is for other scientific and technical consulting services. The opportunity was posted on July 30, 2026, with a firm deadline for responses on August 15, 2026. This subcontract aims to strengthen the nation’s capacity to anticipate and respond to emerging influenza threats by integrating real-time surveillance data with advanced analytical tools to support global influenza strain selection efforts.

Barda - Aspr / Daappo / Barda Dcma

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Regulatory Affairs and FDA BLA Submission ManagementThe contract mandates end-to-end management of Biologics License Application submissions for influenza vaccines, with a primary focus on coordination with the FDA, timely and comprehensive responses to regulatory queries, and ongoing lifecycle management to ensure compliance and continuity. The role requires deep regulatory expertise to navigate the complexities of BLA preparation, submission, and post-submission interactions with federal authorities, ensuring all documentation and scientific data meet stringent regulatory standards. The work is scoped under a subcontract for the Department of Health and Human Services, specifically managed by Barda-ASPR, with performance concentrated in Washington, DC, at the 20024 zip code. The solicitation was posted on July 30, 2026, and responses are due by August 15, 2026, with the North American Industry Classification System code 541611 indicating specialized regulatory affairs and scientific consulting services. The position demands a high level of precision, regulatory fluency, and the ability to operate within strict federal timelines and communication protocols.

Barda - Aspr / Daappo / Barda Dcma

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Vaccine Antigen and Adjuvant ManufacturingThe contract pertains to the manufacture of bulk influenza vaccine antigens and adjuvanted formulations in compliance with current good manufacturing practices for use in clinical trials and emergency response scenarios. The work must adhere to stringent quality and regulatory standards to ensure safety and efficacy, with production intended to support public health preparedness and rapid deployment during outbreaks. The place of performance is designated as Washington, DC, with a delivery deadline for responses set for August 15, 2026. This subcontract falls under the NAICS code 325412, indicating classification within pharmaceutical and medicine manufacturing, and is issued by the Biomedical Advanced Research and Development Authority under the Department of Health and Human Services. Participation requires capability to scale production while maintaining cGMP compliance across all stages of antigen and adjuvant formulation, with no set-aside provisions specified for small or disadvantaged businesses.

Barda - Aspr / Daappo / Barda Dcma

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CMC Regulatory SupportThe contract requires the preparation and submission of Chemistry, Manufacturing, and Controls (CMC) sections for Biologics License Applications (BLAs) focused on influenza vaccines. This includes developing and finalizing process validation protocols, stability study designs, and comprehensive quality control documentation to meet regulatory standards for vaccine approval. The work demands precise adherence to FDA guidelines and the ability to coordinate technical data across manufacturing, testing, and regulatory teams to ensure timely and compliant submissions. The contract is classified as a subcontract under NAICS code 541611 and is issued by the Department of Health and Human Services through Barda - ASPR / DAAPPO / Barda DCMA. Performance is to be carried out in Washington, DC, with a posting date of July 30, 2026, and a hard deadline for responses on August 15, 2026. All deliverables must be structured to support the regulatory pathway for influenza vaccines, emphasizing scientific rigor, operational consistency, and compliance with current good manufacturing practices.

Barda - Aspr / Daappo / Barda Dcma

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Analytical & Nonclinical Testing ServicesThe contract involves the execution of preclinical studies and analytical testing services for influenza vaccine candidates, focusing on critical areas such as toxicology, immunogenicity, potency, and stability assessments to support vaccine development and regulatory submission. These activities are essential for evaluating the safety, biological activity, and consistency of vaccine candidates prior to human trials, ensuring they meet quality and efficacy benchmarks. All work must be conducted in accordance with established scientific and regulatory standards to generate reliable, reproducible data that can inform further advancement of the candidates. The solicitation is designated as a subcontract under NAICS code 541620, with a response deadline of August 15, 2026, and was posted on July 30, 2026. The performance location is identified as Washington, DC, with the contracting agency listed as the Department of Health and Human Services through its Barda - ASPR/DAAPO/Barda DCMA office. While specific award details and point of contact information are not provided, the structure and timing suggest this is part of a broader effort to bolster pandemic preparedness and vaccine readiness under federal public health directives. Respondents are expected to demonstrate technical capability, compliance with nonclinical testing protocols, and experience in vaccine development support.

Barda - Aspr / Daappo / Barda Dcma

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Influenza Vaccine Clinical Trial ManagementThe contract pertains to the design and management of Phase I–III clinical trials for influenza vaccines, encompassing all critical aspects from protocol development and site selection to patient recruitment and regulatory reporting to the FDA. The work requires specialized expertise in infectious disease trials, with a focus on ensuring compliance with regulatory standards and timely submission of clinical data. The performance location is in Washington, DC, with a zip code of 20024, indicating the primary operational base for trial oversight and coordination. This is a subcontract under the Department of Health and Human Services, specifically managed by Barda – ASPR / DAAPPO / Barda DCMA, with a NAICS code of 541711 indicating scientific research and development services. The opportunity was posted on July 30, 2026, with a response deadline of August 15, 2026, at 9:00 PM ET. While no set-aside type or point of contact is specified, the emphasis on end-to-end clinical trial management suggests the subcontractor must possess a proven track record in vaccine development, regulatory engagement, and multi-site trial execution under federal health security initiatives.

Barda - Aspr / Daappo / Barda Dcma

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