CONTROL, RESPIRATORY PA
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This contract is for the procurement of two kits of BioFire RP2.1/RP2.1 Plus Control Panels, used as quality controls for detecting and identifying respiratory pathogens on the FilmArray instrument. Each kit contains 12 vials of synthetic nucleic acid, consisting of six positive and six negative controls of 300ul each, providing enough reagent for six quality control runs. The items must be stored frozen between -25 and -15 degrees Celsius and have a non-extendable shelf life of 18 months, with no more than two months elapsed from the date of manufacture to the date of government delivery. The procurement is managed by the Department of Defense Medical Supply Chain and requires adherence to specific DLA technical, quality, and packaging requirements. All materials must be marked according to Medical Marking Standard No. 1 and packaged in sealed unit containers within suitable commercial shipping containers. The delivery is required within 83 days after the order, and the supplier must ensure all labels include the contract number, lot number, and relevant manufacture and expiration dates.
General Info
Agency
NAICS
Place of Performance
ATTN CL VIII MED REQ PROCES ACT, APO, AE, 09227-0000, USASet-Aside
Documents
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Timeline
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Organization & Contact Information
Full Description
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-382L
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: 2 KT Purchase Request: 7018129894QTY: 2 Delivery: 83 days ADO
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