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TEST KIT, HEPATITIS B S

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SPE2DS-27-T-1226Federal

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

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This solicitation, issued by DLA Troop Support Medical Supply Chain MD SURG FSF, is a Small Business Set-Aside for the procurement of one package of Hepatitis B Surface Antigen Determination test kits (NSN 6550-01-664-2387). Each kit is designed for the in-vitro detection of HBsAg in human serum and plasma and contains 100 coated wells, 6.2 mL of conjugate reagent, and 8.4 mL of assay reagent. The product requires strict refrigeration between 2 to 8 degrees Celsius and must not be frozen. The items have a non-extendable shelf life of 12 months, with a requirement that no more than one month elapses from the date of manufacture to the date of delivery to the government. Delivery is required within 20 days after receipt of order, with the destination and acceptance point located at TAH20 Comfort MTF 250 Bed. Packaging must be commercial and adhere to Medical Marking Standard No. 1, which supersedes MIL-STD-129. Due to the nature of the reagents, suppliers must comply with the Hazard Communication Standard (29 CFR 1910.1200) and submit Safety Data Sheets (SDS) and HCS labels for approval prior to award. Administrative requirements include the use of the Wide Area WorkFlow (WAWF) system for invoicing and compliance with the Buy American Act and DFARS cybersecurity standards for safeguarding covered defense information.

General Info

Small business set-aside for procuring refrigerated Hepatitis B Surface Antigen test kits.

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

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

Set-Aside

NONE

Documents

1
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Timeline

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA

Full Description

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TEST KIT,HEPATITIS B SURFACE ANTIGEN DET
TEST KIT,HEPATITIS B SURFACE ANTIGEN DETERMINATION
FEATURES HBSAG REAGENT 100 WELLS/PK RX; FOR THE INVITRO DETECTION OF
HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA; CONTAINS
100 COATED WELLS, 6.2 ML CONJUGATGE REAGENT IN BUFFER WITH BOVINE SERUM
ALBUMIN, GOAT SERUM, AND ANTIMICROBIAL AGENT, AND 8.4 ML ASSAY REAGENT
WITH HUMAN SERUM, CALF SERUM, MOUSE SERUM AND ANTIMICROBIAL AGENT
REQUIRES REFRIGERATION STORAGE BETWEEN 2 TO 8 DEGREES CELSIUS
(36 TO 46 DEGREES FAHRENHEIT) DO NOT FREEZE
..
UNIT OF ISSUE PG (100 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
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
SPE2DS-27-T-1226
SECTION B
TROOP SUPPORT VIA EMAIL TO contact@example.gov. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
.. RS011: Shelf-life requirement RS001 for a TYPE I (CODE H) item with a shelf life of 12 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 12 MONTHS. NOT MORE THAN 1 MONTH 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. .. RQ034: HAZARDOUS COMMUNICATION STANDARD NOTICE
Hazard Communication Standard Notice:
Effective June 1, 2015, Federal Standard No. 313-E, Material Safety Data, Transportation Data and Disposal Data for Hazardous Materials Furnished to Government Activities, establishes the requirement for preparation and submission of Safety Data Sheets (SDS) in lieu of Material Safety Data Sheets (MSDS) by suppliers who provide hazardous materials to government activities.
The Occupational Safety and Health Administration (OSHA) has modified its Hazard Communication Standard (HCS) to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals. As a result of this change, GSA revised Federal Standard No. 313-E requiring Safety Data Sheets for classifying chemicals and communicating the applicable information on labels.
In accordance with the revised standard after June 1, 2015:
1. Suppliers will be required to submit, to the contracting officer for review and approval prior to award, safety data sheets consistent with the requirements found at 29 C.F.R. 1910.1200 for hazardous materials delivered to the Government.
2. Suppliers will also be required to submit, to the contracting officer for review and approval prior to award, Hazardous Communication Standard (HCS) labels in accordance with 29 C.F.R. 1910.1200 requirements or current Consumer Product Safety Act (CPSA), Federal Hazardous Substance Act (FHSA) labels when subject to labeling requirements under those statutes. This product labeling is required for hazardous materials delivered to the Government.
3. Finally, suppliers must train their employees on the new safety data sheets, hazardous communication labels, and requirements of 29 C.F.R. 1910.1200.
For more information on SDS, refer to OSHAs website, available at:
https://www.osha.gov/law-regs.html
For information on 29 C.F.R. 1910.1200, refer to the below link:
https://www.osha.gov/dsg/hazcom/index.html .. ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-664-2387 Quantity: 1 PG Purchase Request: 7018938271QTY: 1 Delivery: 20 days ADO

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