MODIFICATION
65 -- Cost Per Test-Verigene Kits
- Notice Date
- 8/16/2016
- Notice Type
- Modification/Amendment
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-13-D-5048
- Archive Date
- 10/1/2016
- Point of Contact
- Derek J. Bell, Phone: 3016196914
- E-Mail Address
-
derek.j.bell.civ@mail.mil
(derek.j.bell.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to modify contract N62645-13-D-5048 by re-instating option period 3. The contract is with Nanosphere, 4088 Commercial Avenue Northbrook, IL, 60062-1829, as the only responsible source that can provide service Verigene RV+, RV+ amplification Kit, Verigene BC-GN, Verigene Utility Tray, and Verigene Gram-positive blood culture test kits at Naval Medical Center San Diego. Only the Verigene RV+, RV+ amplification Kit and Verigene Gram-positive blood culture test kits can be used with Nanosphere Verigene laboratory instruments manufactured by Nanosphere, Inc. NMC San Diego currently owns the Nanosphere Verigene processors and readers and the requested Verigene assays are the only ones that are FDA approved to be used with these instruments. No other vendor can provide assays and consumables that are configured to be used with the installed base of Nanosphere Verigene processors and readers. At this point another manufacturers system is unable to replace the one currently onsite because NMCSD would lose their FDA licensure. No other unit can meet the minimum requirements of the government. Regulatory Requirements: The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at derek.j.bell.civ@mail.mil. Statements are due not later than 3:00 PM on 31 Aug 2016. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645-13-D-5048 /listing.html)
- Record
- SN04225936-W 20160818/160816235532-cb18aaca9cc56ac680f35cbf7c3c1761 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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