SSN 36C25626Q1142.pdf

Department of Veterans Affairs

Network Contracting Office (NCO) 16

Sources Sought Notice (SSN)

DISCLAIMER:

This Sources Sought Notice (SSN) is issued solely for informational and market research purposes and does not constitute a solicitation. This notice shall not be construed as a commitment by the Government to award a contract, nor does it obligate the Government to any acquisition action. Responses to this notice are strictly voluntary; the Government will not reimburse any costs associated with responding. Respondents should not include proprietary or restricted information. If a solicitation is issued, it will be posted on SAM.gov. It is the responsibility of the interested parties to monitor this site for additional information pertaining to this SSN.

1. Title

Biotyper Sirius CA System with centrifuge.

2. Purpose

The purpose of this SSN is to identify qualified and capable sources to assist in determining the appropriate acquisition strategy (e.g., small business set‑aside, unrestricted). Responses will support the VA’s market research for an anticipated requirement.

3. NAICS and PSC Information

Primary NAICS: 334516 – Analytical Laboratory Instrument Manufacturing. Small Business

Size Standard: 1,000 employees.

4. Required Vendor Responses

Vendors must provide complete responses to all questions below to be considered responsive to this SSN:

1. Provide the physical location(s) where the offered MALDI‑TOF system, associated software, accessories, reagents, consumables, calibration materials, controls, and mini‑centrifuge are manufactured. Include supporting documentation (e.g., OEM statement, product sheet, or certification).

2. State whether the manufacturer of the offered equipment is a small or large business. If your company is a reseller and not the manufacturer, provide documentation supporting

Non‑Manufacturer Rule (NMR) compliance.

3. Provide current OEM authorization confirming your company is an authorized distributor/reseller of the proposed system and accessories, with access to OEM replacement parts and manufacturer‑approved service resources. Authorization letter must be current (less than one-year old), signed, and confirm new, non‑remanufactured equipment..

4. Provide contractor name, point of contact, address, phone number, email, business size, UEI and CAGE code.

5. Identify whether your company qualifies as SB, SDVOSB, VOSB, HUBZone, or 8(a).

Provide proof of certification (SDVOSB/VOSB must be SBA‑certified under the VetCert program).

6. Identify any GWAC, GSA Schedule (including SINs), IDIQ, or BPA under which these supplies/services are available, including contract numbers.

7. Confirm whether your offered system can meet all salient characteristics listed in the draft

SOW, including FDA‑cleared IVD workflow requirements, 21 CFR Part 11 features, CLIA/CLSI performance expectations, VA cybersecurity/Directive 6550 requirements, and shipping compliance (49 CFR 173.199 / IATA) for any organisms/reagents provided. No technical data needs to be provided at this stage—a yes/no with brief explanation is sufficient.

8. Provide approximate delivery and installation lead time from receipt of order, including site‑readiness considerations.

9. Attach a capability statement describing experience providing:

• Clinical laboratory analyzers

• Medical devices with FDA 510(k) clearance

• Installation, validation, and operator training

• Devices requiring VA cybersecurity reviews (RMF/ATO/Directive 6550)

5. Instructions for Responses

Questions regarding this SSN shall be submitted by 16:00 PM (CST), July 29, 2026, to

William.Shaver@va.gov. Responses must be submitted by 07:00 AM (CST), July 31, 2026, in

Microsoft Word or PDF format to the same email address. Include the subject line: “VAMC

Biotyper Sirius CA System with centrifuge – SSN Response.”

6. Market Pricing

Vendors are encouraged to provide estimated market pricing. Pricing information provided will assist the VA in determining procurement strategy and is considered part of market research only.

7. Additional Information

Information provided will be used solely for market research and will not be released outside the

VA acquisition team. If no responses to this notice are received from an authorized distributor, then this action will be sole sourced to the manufacturer/authorized distributor.

8. Contact Information

William Shaver

William.Shaver@va.gov

9. Background - SOW

Please see the draft Statement of Work (SOW), provided as Attachment A, for additional background and technical information.

mailto:William.Shaver@va.gov