The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 6.302) with Diamedix Corporation, 2140 N. Miami Ave, Miami, FL, as the only source that can provide a brand name only MAGO Plus Automated EIA Analyzer that runs all required tests. Specifically, the Enzyme Analyzer shall run the following required tests:
AUTOIMMUNE DISEASE
ANA ELISA screen
anti-Sm/RNP
anti-B2-Glycoprotien l lgG/lgM
anti-Gliadin lgG
ENA-6 screen
Scl-70
anti-cardiolipin screen
anti-MPO (P-ANCA)
anti-SSA
anti-Jo-1
anti-Cardiolipin lgG/lgM
anti-PR-3 (C-ANCA)
anti-SSB
anti-dsDNA
anti-cardiolipin lgA
anti-TPO
anti-Sm
Rheumatoid Factor
anti-Gliadin lgA
anti-TG
INFECTIOUS DISEASE
Toxoplasma lgG
HSV 1&2 lgG
EBNA-1 lgM
Mycoplasma lgG
Toxoplasma lgM Capture
HSV 1&2 lgM
EBV-EA-D lgG
VZV lgG
Rubella lgG
anti-Borrelia burgdorferi lgG/lgM
EBV-EA-D lgM
Rubella lgM Capture
EBV-VCA lgG
H. pylori lgG
CMV lgG
EBV-VCA lgM
Measles lgG
CMV lgM Capture
EBNA-1 lgG
Mumps lgG
Regulatory Requirements:
The enzyme analyzer and all of its 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.
Each Unit (System) to include all of the following items:
(1) P/N: 251-100
Description: MAGO Plus / Aptus Automated EIA analyzer. Includes shipping, installation, and on site training.
(2) P/N:
Description: Manuals
(3) P/N:
(4) Description: 12 month Warranty
This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 325413 with a Small Business Size Standard of 500 employees. 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, including cost, sufficient to determine capability in providing the same product. All capability statements, to include proof of distributorship of brand name only item, received within 5 business days after publication 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 normally 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 Jan Harding at
[email protected]. Statements are due by 4:00 PM est, 7 August 06. No phone calls accepted.
Bid Protests Not Available