PLASMA CONTROL, NORMAL LEVEL

PLASMA CONTROL, NORMAL LEVEL is a certified quality control solution intended exclusively for use with citrated plasma samples in coagulation testing, specifically for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) assays on the NS 6630-01-519-3589 coagulation analyzer. Each packaging unit contains 15 vials arranged in 4 sleeves, and the product must be stored refrigerated between 2°C and 8°C (36°F–46°F) to maintain stability. It is classified as a TYPE I (CODE G) medical device with a non-extendable shelf life of 9 months, strictly regulated by the FDA, and must be procured under the specified part number 000DCJCPT-N supplied by WERFEN USA LLC. The item is identified by NSN 6550-01-519-7696 and requires compliance with Medical Marking Standard No. 1, superseding MIL-STD-129, with all packaging and labeling meeting DLA specifications for containment, protection, and shipping integrity. The contract requires delivery of two packaging groups (PG), each containing 15 vials, for a total of 30 vials, under solicitation SPE2DS-26-T-221S with a delivery deadline of 84 days to APO 96260-5479, FOB destination. Inspection and acceptance occur at the delivery point with zero tolerance for quantity variance. All packaging must conform to MIL-STD-2073-1E guidelines and incorporate proper commercial shipping containers suitable for safe transport by common carriers at the lowest cost. The bidder must provide the exact source and part number, and the acquisition is subject to DLA’s technical and quality requirements as outlined in their Master List, with mandatory referral through EBS to confirm regulatory compliance. The product is designated for federal medical procurement under the Department of Defense, and all documentation must adhere to the applicable federal acquisition standards and marking protocols.