This Combined Synopsis/Solicitation opportunity was posted on May 23, 2017. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Notice of Intent to Award a Sole Source Contract for MIoBS ELISA Test Kits

Closed

FDA-SS-1183853Federal

Submission Closed06/05/2017, 08:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325413

New

Federal

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Certified Industrial Wastewater Laboratory TestingThis subcontract opportunity is for certified industrial wastewater laboratory testing to support prime contractors on Department of Veterans Affairs Medical Center projects located in Huntington, West Virginia. The selected provider will be responsible for analyzing wastewater samples for Total Phenolics, Oil and Grease, Flashpoint, Acrolein, and a full list of Volatile Organic Compounds. All testing must be conducted using EPA analytical procedures as specified in 40 CFR Part 136, and the provider must deliver formal certified laboratory analysis reports. To be eligible, the contractor must hold a valid State of West Virginia certification for wastewater testing and possess specialized instrumentation required for VOC detection. This requirement falls under NAICS code 325413 and is managed through the Department of Veterans Affairs Network Contract Office 5. Interested parties should note the response deadline of November 16, 2026.

245-NETWORK Contract Office 5 (36C245)

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Cost Per Reportable Result Purchase of Immunohistochemistry Reagents for Laboratory Tests.

Solicitation # 36C26027Q0058

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BCL27*390093-Beckman-Reagents-mobile

Solicitation # SRC0000037207

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6550--HEMOCHRON SIGNATURE ELITE REAGENTS AND SUPPLIES

Solicitation # 36C26227Q0046

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Solicitation # 2139989

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TEST KIT, CORONAVIRUS D

Solicitation # SPE2DS-27-T-0714

Solicitation SPE2DS-27-T-0714 is issued by the Defense Logistics Agency for the procurement of one case of Abbott BinaxNOW COVID-19 Antigen self-test kits for over-the-counter, at-home use. Each case contains 12 kits with 2 tests per kit. The items must be stored between 2 and 30 degrees Celsius and must have a non-extendable shelf life of 12 months, with no more than one month elapsed from the date of manufacture to the date of delivery. Delivery is required within 20 days after receipt of order, with the FOB and inspection/acceptance points set to destination. The contractor must adhere to Medical Marking Standard No. 1 for all labeling, ensuring the inclusion of the contract or lot number and the manufacture, expiration, or retest date. Packaging must be commercial, utilizing sealed unit containers and suitable exterior shipping containers in accordance with DLA packaging requirements and MIL-STD-2073-1E. Administrative requirements include the use of the Wide Area WorkFlow system for invoicing and compliance with the Buy American and Balance of Payments Program. The solicitation is categorized under NAICS code 325413 and incorporates various FAR and DFARS clauses regarding cybersecurity, safeguarding covered defense information, and the HUBZone price evaluation preference.

MEDICAL SUPPLY CHAIN MD SURG FSF

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Supply of Antibody Identification Panel CellsThis subcontract involves the manufacture and delivery of antibody identification panel cells for prime contractors supporting Department of Veterans Affairs Network Contract Office 20 medical supply projects. These red blood cell reagents are critical for matching donated blood products to recipients within Surgery, Oncology, Emergency, and Medical Units, with shipments specifically destined for the Boise VA Medical Center. The provider must maintain strict compliance with clinical standards and hold Federal Supply Schedule status under Group 66 III Cat 605-2A. Operating under NAICS code 325413, the contract is managed by the Department of Veterans Affairs with performance associated with the Vancouver area.

260-NETWORK Contract Office 20 (36C260)

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Supply of Quality Control Check CellsThis subcontract involves the manufacture and delivery of specialized red blood cell quality control check cells for the Department of Veterans Affairs Network Contract Office 20. These reagents are critical for validating patient testing within the Transfusion Services Department and are delivered specifically to the Boise VA Medical Center. The provider must maintain strict quality control standards and hold Federal Supply Schedule status under Group 66 III Cat 605-2A. Operating under NAICS code 325413, the contract ensures that prime contractors on medical supply projects have the necessary materials to maintain clinical accuracy and regulatory compliance.

260-NETWORK Contract Office 20 (36C260)

POSTED

6 days ago

DEADLINE

in 5 days

General Info

Agency

N/A

Contract Value

$38,920

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

5100 Paint Branch Parkway College Park MD, 20740-3835 , USA, COLLEGE PARK, MD, 20740, USA

Set-Aside

NONE

Awardee

CRYSTAL CHEM INC

Award Issued Date

06/14/2017, 12:00:00 AM UTC

Documents

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed

PostedMay 23

Combined Synopsis

Response DeadlineJun 5

Deadline has passed

Submission Closed

06/05/2017, 08:00:00 PM UTC

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Organization & Contact Information

AgencyN/A

Contacts1 person available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Lisa K. Yaw

contact@example.gov

+1 (555) 000-0000

Full Description

Notice of Intent to Award a Sole Source Contract for MIoBS ELISA Test Kits The Food and Drug Administration intends to make a sole source award for MIoBS ELISA Test Kits in the amount of $38,920. The award will be made to: Crystal Chem, Inc. 1536 Brook Drive, Suite A Downers Grove, IL 60515 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires test kits in support of method development for the detection of undeclared food allergens and gluten. These test kits are unique in their sensitivity (0.3 ?g/mL), specificity, and reliability as demonstrated in multi-laboratory validations. In addition, the FDA has recognized the uniqueness of these test kits in the Gluten-free Regulation published in the Federal Registry, as official methods required for the analysis of regulatory samples, required for use in FDA field assignments. The methods currently being employed by the FDA for regulatory enforcement involve the use of analyte specific ELISA technology to detect seven of the eight major food allergens; namely, egg, gluten/wheat, milk, peanut, tree nut (almond, hazelnut, and walnut), crustacean shellfish, and soy protein. The most sensitive of these methods are those developed by MIoBS (Morinaga Institutes of Biological Sciences, Inc.) with limits of detection (LOD values) of 0.4 g/mL. These MIoBS ELISA Test Kits have been demonstrated to be reliable in multi-laboratory validation studies besides required for the analysis of regulatory samples are used to visualize proteins in Western Blots and was cited in a proposed regulation for fermented and hydrolyzed gluten published in the Federal Register. Substitute ELISA test kits are not acceptable due to the unique features of the MIoBS ELISA test kits. The NAICS code for this action is 325413. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements. This is a notice of intent to issue an award on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item to: Lisa Yaw Contracts Specialist Lisa.Yaw@fda.hhs.gov 240-402-4018 A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about June 5, 2017.

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