SOLICITATION NOTICE
66 -- Kidney Assay Kits
- Notice Date
- 8/9/2010
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, NCTR-50 RM422 HFT-320, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1075401
- Archive Date
- 9/18/2010
- Point of Contact
- Marcia O Park, Phone: (870) 543-7405
- E-Mail Address
-
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Award Number
- na
- Award Date
- 8/19/2010
- Description
- The HHS/FDA intends to award on a sole source basis, 25 K15156C-2 Argutus Acute Kidney Injury, 25 K153HXC-2 Clusterin and 25 K15162C-2 Kidney Injury Panel kits to Meso-Scale Discovery of Gaithersburg, Maryland. Description of Supplies or Services: These microplate assay kits for detecting kidney damage are required for detecting kidney damage to complete the ongoing FDA studies on chemical contaminants. The kits are specifically configured and designed to be used with the currently in use MSD SECTOR Imager 2400 currently located in the White Oak FDA toxicology laboratories. The Imager provides a method to rapidly quantitate the results from the microplate assay kits. Statutory Authority: 41 U.S.C. 253c; FAR 6.302-1 Only one responsible source and no other supplies or sources will satisfy agency requirements. Validity of Use of Statutory Authority: Meso-Scale Discovery is currently the sole supplier of the biomarker microplate assay kits for detecting assay kits for detecting kidney damage which were specifically designed to operate with the SECTOR Imager 2400 instrument manufactured and sold solely by Meso-Scale Discovery. The SECTOR Imager 2400 is compatible only with microwell plates and immunoassay kits sold by MSD and vice versa. The Imager is currently used in the CDRH – Division of Biology Laboratory of Toxicology. This specific technical hardware is needed to meet FDA/CDRH program responsibilities. Studies are currently being conducted to address concerns stemming from a major recall of pet food in the Spring of 2007 in North America when clinical observations of acute renal failure in cats and dogs were associated with consumption of wet pet food. These kits are needed to measure kidney damage. All responsible sources may sub a capability statement which shall be considered by the interested parties. Award Date August 19, 2010.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1075401/listing.html)
- Place of Performance
- Address: CDRH, Office of Science and Engineering Laboratories, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02234017-W 20100811/100809235437-5fc9fbb48e88a764d974bb9734a07961 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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