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CONTROL, RESPIRATORY PA

Active
SPE2DS-26-T-311FFederal

Contract Overview

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

AI Contract Overview

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The BioFire RP2.1/RP2.1plus Control Panel is a synthetic nucleic acid-based quality control product consisting of 12 vials, each containing 300 microliters of a non-infectious buffer solution with stabilizers and preservatives. It is designed for in vitro use with the FilmArray instrument to monitor the detection and identification of respiratory pathogens during RP2.1 panel testing. Each kit provides sufficient reagent for six quality control runs, including six positive and six negative controls. The product requires strict frozenstorage between -25°C and -15°C (-13°F to 5°F) and has a non-extendable shelf life of 18 months, with no more than two months allowed to have passed from the date of manufacture to delivery to the government. Labeling must include the date of manufacture, expiration date, contract number, and lot number in compliance with Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must meet commercial standards, ensuring protection against damage, with exterior containers suitable for safe transport at the lowest cost to the specified delivery point. The item is governed by DLA technical and packaging requirements, including RS013 for shelf life, RP001 for packaging standards, and RD003 for potential covered defense information. The National Stock Number is 6550-01-690-4435, with a procurement quantity of three kits under solicitation SPE2DS-26-T-311F, with a delivery deadline of 83 days after award.

General Info

12-vial synthetic control panel for FilmArray respiratory testing, frozen storage, 18-month shelf life, three kits ordered under DLA specs.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSFView Agency

NAICS

325413 - In-Vitro Diagnostic Substance ManufacturingView NAICS

Place of Performance

ATTN CL VIII MED REQ PROCES ACT, APO, AE, 09227-0000, US

Set-Aside

NONE

Documents

(1)

SPE2DS-26-T-311F.pdf

PDF

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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
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Office AddressUS

Full Description

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CONTROL,RESPIRATORY PANEL
CONTROL, RESPIRATORY PANEL
THE BIOFIRE RP2.1/RP2.1PLUS CONTROL PANEL
CONSISTS OF 12 VIALS SYNTHETIC NUCLEIC ACID
SUSPENDED IN A NON-INFECTIOUS SOLUTION OF
BUFFERS, PRESERVATIVES AND STABILIZERS; IT
IS INTENDED FOR IN VITRO USE AS A QUALITY
CONTROL TO MONITOR THE DETECTION AND
IDENTIFICATION OF RESPIRATORY PATHOGENS AS
PERFORMED BY THE FILMARRAY RP2.1 PANEL ASSAY
ON THE FILMARRAY INSTRUMENT; EACH KIT CONTAINS
ENOUGH REAGENT FOR 6 QUALITY CONTROL RUNS
..
REQUIRES FROZEN STORAGE AT -25° CELSIUS TO -15° CELSIUS (-13° FAHRENHEIT
TO 5° FAHRENHEIT).
..
UNIT OF ISSUE: KT (KIT CONTAINS 12 TUBES X 300UL, 6 POSITIVE CONTROLS
AND 6 NEGATIVE CONTROLS)
..
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-311F
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/
.. RS013: Shelf-life requirement RS001 for a TYPE I (CODE K) item with a shelf life of 18 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 18 MONTHS.
NOT MORE THAN 2 MONTHS 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.
..
REQUIRES FROZEN STORAGE AT -25° CELSIUS TO -15° CELSIUS (-13° FAHRENHEIT
TO 5° FAHRENHEIT).
..
ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-690-4435 Quantity: 3 KT Purchase Request: 7017761632QTY: 3 Delivery: 83 days ADO

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