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CONTROL, RESPIRATORY

Active
SPE2DS-26-T-246LFederal

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 CONTROL, RESPIRATORY PANEL consists of a synthetic nucleic acid control panel designed for in vitro use with the FilmArray RP2.1 assay system to monitor the detection and identification of respiratory pathogens. Each kit contains twelve 300 µL vials suspended in a non-infectious buffer solution with preservatives and stabilizers, evenly divided into six positive and six negative controls for quality assurance during testing on the FilmArray instrument. The product requires storage at -25°C to -15°C (-13°F to 5°F) and has a strict shelf life of 18 months from manufacture, with no extensions permitted; no more than two months may have elapsed between manufacture and government delivery. All packaging must comply with Medical Marking Standard No. 1, replacing MIL-STD-129, and must include the date of manufacture, expiration or retest date, contract number, and lot number. The unit is shipped in sealed commercial containers suitable for protection and safe transport by common carrier at the lowest rate, with export packaging when required. The item is subject to DLA packaging requirements, defense information controls, and removal of government identification from non-accepted supplies, and is identified under NSN 6550-01-690-4435 with an anticipated delivery within 20 days after order. The acquisition is governed by the SOLICITATION SPE2DS-26-T-246L, issued by the Department of Defense through the Medical Supply Chain MD Surg FSF office.

General Info

Synthetic nucleic acid control panel for FilmArray RP2.1, stored at -25°C to -15°C, 18-month shelf life, DLA-compliant packaging, NSN 6550-01-690-4435.

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-246L Medical Supply Chain

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Timeline

PhaseSolicitation
Posted

Solicitation

Response Deadline

Submission deadline

Response Deadline

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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
Marc Canalichio
contact@example.gov
+1 (555) 000-0000

Full Description

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CONTROL,RESPIRATORY
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-246L
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: 1 KT Purchase Request: 7017325202QTY: 1 Delivery: 20 days ADO

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