PLASMA CONTROL, NORMAL LEVEL

This contract specifies the procurement of Plasma Control, Normal Level, a quality control solution designed for citrated plasma samples used in prothrombin time (PT) and activated partial thromboplastin time (APTT) coagulation testing. The product is intended exclusively for use with citrated PT and APTT cuvettes on the NS 6630-01-519-3589 coagulation analyzer and is supplied in a package of 15 vials with 4 sleeves. It requires refrigeration between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit) to maintain stability. The item is regulated by the FDA and has a non-extendable shelf life of nine months, classified as a Type I (Code G) item under shelf-life requirements. The supplier must provide Werfen USA LLC’s part number 000DCJCPT-N and confirm the source and part number as specified. The contract mandates strict packaging and labeling compliance with Medical Marking Standard No. 1, superseding MIL-STD-129, and requires all units to be sealed and protected within commercial exterior shipping containers suitable for safe transport by common carriers at the lowest cost to the designated delivery point. The item must adhere to MIL-STD-2073-1E packaging standards and include proper government marking as defined by DLA guidelines. Delivery is required FOB destination within 20 days with zero tolerance for variance in quantity. Inspection and acceptance occur at the destination. The contract is issued under solicitation SPE2DS-26-T-231H, with the NSN 6550-01-519-7696 and purchase request 7017473099, subject to DLA’s technical and quality requirements as outlined in their master list. Bidder information, manufacturer details, and product specifications must be submitted for FDA referral through the EBS system.