SAM #2026-Q-98331

CDC Seeks Roche cobas 4800/6800 HIV Test Kits, Consumables, and Maintenance Services

The Centers for Disease Control and Prevention (CDC), International Laboratory Branch, Division of Global HIV & TB, Global Health Center, is seeking maintenance, service, and supply support for Roche cobas 4800 and 6800 laboratory systems used for HIV viral load and early infant diagnosis (EID) testing. - Government Buyer: - Centers for Disease Control and Prevention (CDC) - International Laboratory Branch, Division of Global HIV & TB, Global Health Center - OEM Highlight: - Roche Diagnostics Corp is the sole OEM and provider for all equipment, reagents, consumables, and maintenance services - Products/Services Requested: - cobas 58/68/8800 HIV test kits (reagents for HIV viral load testing) - cobas 58/68/8800 HIV-1/HIV-2 QUAL test kits (reagents for EID qualitative testing) - Consumables and ancillary reagents for cobas 6800 System - Preventative maintenance, service, parts, labor, and repairs for cobas 4800 and 6800 Systems - Remote and on-site technical support by qualified Roche service engineers - Notable Requirements: - All reagents and consumables must have a minimum 12-month shelf life upon delivery - Supplies must be delivered within 30 days of award or by the contract end date, whichever is earlier - Maintenance and repairs must follow manufacturer guidelines to maintain warranty and guarantee coverage - Both remote and on-site technical support are required - No other OEMs or vendors are mentioned; Roche Diagnostics is the exclusive provider due to proprietary manufacturing and service requirements.

Description

The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) International Laboratory Branch intends to award a firm-fixed price, sole source purchase order to Roche Diagnostics Corp, 9115 Hague Road, Indianapolis, Indiana 46556-1025 for the purchase of Maintenance Services for the Roche cobas® 4800 and cobas® 6800 .

The authority for this sole source acquisition is in accordance with FAR Part 5.203 and FAR Part 12.102(a).

Roche Diagnostics Coporation is currently the only company that possess proprietary manufacturing processes and maintenance of their equipment; thus the only authorized service provider for the Roche cobas® 4800 and cobas® 6800  equipment. Any services provided from other sources will void any warranties or guarantees and may forfeit services by Roche Diagnostics equipment if requested. Accordingly, because this is the instrument that the lab currently uses and requires for their work, no other retailer can provide the required maintenance, repairs, replacements and/or services of the equipment.

As a result of this synopsis, a separate solicitation is not required and will not be posted on sam.gov.  However, responsible sources that believe they can meet these requirements are encouraged to identify themselves and give written notice by providing a capability statement to the Contracting Officer by the closing date of this posting. The Contracting Officer will not respond to verbal request. All requests must be in writing.

A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. 

Inquiries shall be sent to Debra Baker by email at xvv9@cdc.gov and reference solicitation #2026-Q-98331 on the subject line.

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