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Preventative Maintenance and Service Support for Miltenyi Biotec CliniMACS Plus Instruments
National Institutes of Health · NATIONAL INSTITUTES OF HEALTH OLAO
Respond by: Nov 4, 2026, 7:00 AM UTC−55 days left
From SAM.gov's public data file generated Oct 29, 2026, 3:30 AM UTC; newest notice posted Oct 29, 2026; loaded into FedSub Oct 29, 2026, 5:46 AM UTC
Notice facts
Source: SAM.gov Contract Opportunities public data file
- Solicitation number
- 27-000190
- Notice type
- Presolicitation
- Posted
- Oct 26, 2026
- Response date
- Respond by Nov 4, 2026, 7:00 AM UTC−5
- Set-aside
- None stated
- NAICS code
- 811210 Electronic and Precision Equipment Repair and Maintenance
- Product or service code
- J066
- Place of performance
- Bethesda, MD 20892
- Contracting office
- NATIONAL INSTITUTES OF HEALTH OLAO (75N980)BETHESDA, MD 20892
- Agency
- Department of Health and Human Services · National Institutes of Health
Past prime awardees
Source: Award history, not a list of bidders on this notice
Past prime awardees · award history, not a list of bidders on this notice
10 companies held prime contracts from this office under NAICS 811210.
- FEI COMPANY · No first-tier subawards reported in FedSub's data
9 more past prime awardees on Professional
Description
Source: SAM.gov Contract Opportunities public data file
The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to procure preventative maintenance and service support for seven (7) Miltenyi Biotec CliniMACS Plus instruments from Miltenyi Biotec, Inc. The requirement supports the continued operation of critical cell-processing equipment used in manufacturing patient-specific cellular therapies for patients enrolled in clinical trials at the NIH Clinical Center. CCE manufactures cell-based therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The requirement includes preventative maintenance, calibration, inspections, software updates, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support for CliniMACS Plus instruments bearing serial numbers 2600, 2602, 2632, 2635, 2634, 2619, and 2756. These services are necessary to maintain equipment reliability, validated manufacturing processes, and compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Miltenyi Biotec, Inc., is the original equipment manufacturer and the only known authorized provider capable of performing the required preventative maintenance, calibration, and technical support services for the CliniMACS Plus instruments. The equipment incorporates proprietary software, diagnostic tools, replacement parts, and manufacturer-specific technical requirements that are not available to unauthorized third-party service providers. The seven instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an alternate service provider without the required manufacturer authorization, proprietary software access, and technical expertise could compromise equipment performance, jeopardize regulatory compliance, and…
Versions on SAM.gov
Source: SAM.gov Contract Opportunities public data file
Posted Oct 26, 2026PresolicitationCurrent version
Respond by Nov 4, 2026, 7:00 AM UTC−5
This version on SAM.gov (opens SAM.gov in a new tab)