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CALIBRATOR SET, HUMA

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SPE2DS-26-T-239VFederal

Contract Overview

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

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The contract is for the procurement of Calibrator Sets for Human Chorionic Gonadotropin (hCG), specifically designed for use with the VITROS ECI/ECIQ, VITROS 3600, and VITROS 5600 immunodiagnostic systems to enable quantitative measurement of hCG and its B-subunit in human serum and plasma. Each package contains three sets of calibrators labeled as Level 1, 2, and 3, along with a calibration card, protocol card, and 24 bar code labels for system integration. The product requires refrigerated storage between 2 to 8 degrees Celsius and must not be frozen. The unit of issue is PG, with four packages ordered totaling twelve individual calibrator sets. The item has a non-extendable shelf life of six months, with no more than two weeks allowed to have passed from the date of manufacture to the date of government delivery. All packaging and labeling must comply with Medical Marking Standard No. 1 (MMS No. 1), replacing MIL-STD-129, and must clearly display the date of manufacture, expiration date, contract number, and lot number. Packaging must be commercial grade, sealed, and capable of protecting contents from damage, with exterior containers suitable for safe delivery by common carrier at the lowest cost to the designated delivery point. The procurement is governed under solicitation SPE2DS-26-T-239V, issued by the Department of Defense through the Medical Supply Chain MD Surg FSF, with delivery required within 20 days of award, and the contract incorporates technical, quality, and packaging requirements from the DLA Master List as referenced.

General Info

Procurement of twelve hCG calibrator sets for VITROS systems, refrigerated, six-month shelf life, comply with MMS No. 1, delivery in 20 days.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSFView Agency

NAICS

325413 - In-Vitro Diagnostic Substance ManufacturingView NAICS

Place of Performance

USNS COMFORT T AH 20, FPO, AE, 09566-4008, US

Set-Aside

NONE

Documents

(1)

RFQ SPE2DS-26-T-239V Medical Supply Chain

PDFrfq

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Timeline

PhaseSolicitation
Posted

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
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Office AddressUS

Full Description

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CALIBRATOR SET,HUMA
CALIBRATOR SET, HUMAN CHORIONIC GONADOTROPIN
FEATURES VITROS TOTAL B-HCG II CALIBRATORS 3SETS/PK RX;
FOR USE IN THE CALIBRATION OF THE VITROS
ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS
3600 IMMUNODIAGNOSTIC AND THE VITROS 5600
INTEGRATED SYSTEM FOR THE QUANTITTATIVE
MEASUREMENT OF HUMAN CHORIONIC GONADOTROPIN
HCG AND ITS B-SUBUNIT IN HUMAN SERUM AND
PLASMA; CONTAINS 3 SETS OF VITROS TOTAL
B-HCG II CALIBRATORS 1, 2, AND 3, LOT
CALIBRATION CARD, PROTOCOL CARD, AND 24
CALIBRATOR BAR CODE LABELS
REQUIRES REFRIGERATION STORAGE BETWEEN 2 TO 8 DEGREES CELSIUS
(36 TO 46 DEGREES FAHRENHEIT) DO NOT FREEZE
UNIT OF ISSUE: PG (3 EACH PER PACKAGE)
..
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.
..
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
..
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
..
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
..
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
SPE2DS-26-T-239V
SECTION B
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/
.. RS008: Shelf-life requirement RS001 for a TYPE I (CODE F) item with a shelf life of 6 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 6 MONTHS. NOT MORE THAN 2 WEEKS SHALL HAVE ELAPSED FROM DATE OF MANUFACTURE TO DATE OF DELIVERY TO THE GOVERNMENT. . SHELF LIFE MARKINGS SHALL BE IN ACCORDANCE WITH THE LATEST REVISION OF MMS1C.
. ALL LABELS SHALL INCLUDE:
DATE OF MANUFACTURE, EXPIRATION, OR RETEST DATE CONTRACT NUMBER/LOT NUMBER.
ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-670-5437 Quantity: 4 PG Purchase Request: 7017325253QTY: 4 Delivery: 20 days ADO

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