Inactive

In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires the purchase and delivery of ELISA Test Kits developed ... In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires the purchase and delivery of ELISA Test Kits developed by Moringa Institutes of Biological Sciences, Inc. (MIoBS), which will be used for food allergen detection. the project for which this contract is being issued requires MIoBS ELISA test kits. These test kits are unique in their sensitivity (0.3 ?g/mL), specificity, and reliability as demonstrated in multi-laboratory validations (J Food Hyg Soc Japan 2004, 45:120; J AOAC Intl 2006, 89:1600; J AOAC Intl 2007, 90:427). In addition, the FDA has recognized the uniqueness of these test kits in the Gluten-free Regulation published in the Federal Registry ([Federal Register Aug 5, 2013, 78:47154-47179, Doc. 2013–18813), as official methods required for the analysis of regulatory samples (CMS or Sample # 57152, 116472, 123641, 136851, etc), required for use in FDA field assignments (DFPG Assignment No.: 14-14, ORA concurrence number is 2014041501; DFPG Assignment No.: 15-13), and cited in several scientific papers published by the FDA (J Food Prot 2015, 78:1167; J Food Prot 2015, 78:1237; J Ag Food Chem 2015, 63:10525). Crystal Chem, Inc is the exclusive distributor of MIoBS ELISA test kits in the U.S. Substitute ELISA test kits are not acceptable due to the unique features of the MIoBS ELISA test kits.