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65--Cost/Test Reagents for Intellipath FLX

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VA24616N1516Federal

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The Veterans Affairs Network Contracting Office 6 plans to negotiate a sole source contract with Biocare Medical, LLC for the purchase of reagents and consumables required to operate the Biocare Medical Intellipath FLX immunohistochemistry analysis device. The purchase order will cover proprietary reagents and supplies uniquely developed by Biocare Medical for this device, including specific antibodies and staining kits such as P40, P63, PIN-4, MACH4HRP Polymer, DAB Chromogen Kit, and others. Biocare Medical is the sole authorized manufacturer and distributor of these materials, complying with FDA regulations for medical device manufacturing practices. This procurement is being conducted pursuant to specific Federal Acquisition Regulations and the Clinger-Cohen Act, and it is not a solicitation for competitive proposals. However, potential suppliers who believe they can meet the requirements may submit capability statements by a specified deadline. The decision whether to compete the contract further rests solely with the government, and no phone inquiries are permitted. The contract is identified under solicitation number VA24616N1516 and relates to NAICS code 325413, which covers the manufacturing of biological products and chemical reagents.

General Info

VA plans sole source contract with Biocare Medical for proprietary immunohistochemistry reagents and consumables.

Agency

N/A

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Full Description

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Veterans Affairs Network Contracting Office 6 (NCO 6) intends to negotiate on a sole source basis with Biocare Medical, LLC (DUNS: 806617825), pursuant to FAR Subpart 13.5, FAR 13.106-1(b)(2) and Section 4202 of the Clinger-Cohen Act of 1996. The proposed sole source purchase order is for estimated quantities of reagents and consumables necessary for the operation of a Biocare Medical brand immunohistochemistry analysis device, known as the Intellipath FLX. The list of reagents and consumable supplies includes proprietary formulas developed by Biocare Medical for use in the Intellipath FLX. The list of unique, proprietary antibodies includes P40, P63, PIN-4 (CK5+CK14+P63+P504S), MACH4HRP Polymer, DAB Chromogen Kit, WARP RED, MACH 2 Double Stain 1, MACH 2 Double Stain 2 and BORG. Biocare does not have authorized distributors and is the sole source, responsible manufacturer and distributor, subject to the Federal Drug Administration's (FDA) requirements for Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (GMP), under 21 CFR part 820. This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Wednesday, September 7, 2016, 05:00PM EST. Interest/capability statements may be sent to Daniel Spaulding, Contract Specialist, at contact@example.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

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