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PLASMA CONTROL, NORMAL

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SPE2DS-26-T-221SFederal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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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.

General Info

9-month shelf life PT/APTT plasma control for NS 6630, 30 vials, refrigerated, FDA-regulated, DLA-compliant, FOB destination.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSFView Agency

NAICS

621410 - Family Planning CentersView NAICS

Place of Performance

UNIT 15479, APO, AP, 96260-5479, US

Set-Aside

NONE

Documents

(1)

RFQ SPE2DS-26-T-221S Medical Supply Chain

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Timeline

PhaseSolicitation
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Solicitation

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
View Agency Profile
Office AddressUS
Contacts
Seth Tootell
contact@example.gov
+1 (555) 000-0000

Full Description

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PLASMA CONTROL,NORMAL LEVEL
PLASMA CONTROL, NORMAL LEVEL,
FOR CITRATED PT AND APTT COAGULATION
TESTING, FOR USE AS A NORMAL LEVEL
CONTROL SOLUTION FOR CITRATED SAMPLES
FOR BOTH PT AND APTT COAGULATION TESTING;
NORMAL LEVEL QC FOR USE WITH CITRATE PT
AND CITRATED APTT CUVETTES ONLY. 15 VIALS
WITH 4 SLEEVES. FOR USE WITH COAGULATION
ANALYZER NS 6630-01-519-3589.
.
REQUIRES REFRIGERATION BETWEEN 2
AND 8 DEGREES C (36 DEGREES 46 DEGREES F).
.
.
1 PG = 15 EA
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
SPE2DS-26-T-221S
SECTION B
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
.
BIDDER SHALL SPECIFY SOURCE AND
PART NUMBER BEING SUPPLIED.
.
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description. RS009: Shelf-life requirement RS001 for a TYPE I (CODE G) item with a shelf life of 9 months (non-extendable) applies to this item.
WERFEN USA LLC 22270 P/N 000DCJCPT-N
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7017457313 0001 PG 2.000
NSN/MATERIAL:6550015197696
DELIVERY (IN DAYS):0084
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6550-01-519-7696 Quantity: 2 PG Purchase Request: 7017457313QTY: 2 Delivery: 84 days ADO

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