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TEST KIT, BACTERIA

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SPE2DS-27-T-0243Federal

Contract Overview

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

General Info

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

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

Set-Aside

NONE

Documents

1

RFQ SPE2DS-27-T-0243

PDF, High priority: read this first19 pages · rfq
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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,BACTERIA
TEST KIT,BACTERIA
FEATURES TEST KIT, CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE; THIS
IS AN IN-VITRO DIAGNOSTIC TEST KIT FOR THE QUALITATIVE DETECTION OF DNA
FROM CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHOEAE (NG). THE
APPROXIMATE TIME TO OBTAIN A RESULT IS 90 MINUTES PER TEST. IT IS
INTENDED FOR USE WITH HUMAN URINE, VAGINAL SWAB, AND ENDOCERVICAL SWAB
SPECIMENS. EACH KIT CONTAINS THE NECESSARY REAGENTS AND CONSUMABLES FOR
10 INDIVIDUAL TESTS. THE PRIMARY COMPONENTS ARE: TEN (10) SINGLE-USE
TEST CARTRIDGES, TEN (10) DISPOSABLE TRANSFER PIPETTES.
SHALL BE STORED RIGHT SIDE UP AT 2 28 DEGREES CELSIUS
UNIT OF ISSUE: PG (10 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
SPE2DS-27-T-0243
SECTION B
(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/
.. RS016: Shelf-life requirement RS001 for a TYPE I (CODE M) item with a shelf life of 24 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 24 MONTHS. NOT MORE THAN 3 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. .. 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: 6550-01-737-8661 Quantity: 2 PG Purchase Request: 7018603837QTY: 2 Delivery: 20 days ADO

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