CONTROL SET, GASTROINTESTINAL

The contract calls for the procurement of a Gastrointestinal Control Set, a non-infectious quality control kit designed for in vitro use with the FilmArray Gastrointestinal Panel Assay on the FilmArray instrument. Each kit contains 12 vials, each with 200 µL of synthetic nucleic acid suspended in a buffered solution of preservatives and stabilizers, sufficient for six quality control runs, composed of six each of part numbers M2393718 and M2402818. The product must be stored frozen between -25°C and -15°C and has a fixed shelf life of 18 months, non-extendable, per Type I (Code K) requirements. The item is regulated by the FDA, and the contracting official must submit a referral to confirm regulatory compliance. The required quantity is three kits, to be delivered within 83 days after receipt of order via FOB Destination to APO AE 09227-0000, with zero variance allowed in quantity. Packaging must comply with commercial standards as specified, using sealed unit containers that prevent breakage, and must be shipped in exterior containers ensuring safe delivery at the lowest carrier rate. All labeling and marking must adhere to the Medical Marking Standard No. 1, superseding MIL-STD-129, with palletization following DLA Packaging Requirements. The kit is classified as a covered defense information item, requiring compliance with safeguarding and cyber incident reporting standards under DFARS 252.204-7012, and incorporates additional DFARS clauses addressing hazardous materials, export controls, whistleblower protections, and prohibitions on certain Chinese military company products. The contractor must specify the source and part number supplied, submit bids via DIBBS, and comply with electronic payment and invoicing requirements through WAWF. The contract is an automated award and not a small business set-aside, with payment routed according to the resulting award documentation.