A-A-51383A
After the Neisseria Enrichment Medium is added to Chocolate Agar in accordance with the procedure indicated on accompanying directions for preparation, the growth and colony size of cultures of Neisseria gonorrhoeae, Neisseria meningitides and Hemophilus influence shall be typical and characteristics when tested using a suitable, accurate and reproducible method.
Workmanship. Product shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing five vials of lyophilized media (stable dehydrated powder), each of which can be restored to 10 ml of medium and five 10 ml vials of sterile reconstituting fluid, together with directions for preparation of the medium, as specified, constitutes one unit.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580 to the maximum extent practical.
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