$24,901
10X GENOMICS, INC.
National Institutes of Health
- PIID
- 75N98026F00002
- PSC
- 6505 - DRUGS AND BIOLOGICALS
Federal NAICS Codes
NAICS 325413
In-Vitro Diagnostic Substance Manufacturing
Explore obligations, trends, recent awards, and incumbent contractors for NAICS 325413.
NAICS 325413 federal market metrics
- Total obligations
- $13.7B
- Total awards
- 42,803 awards
- Active obligations
- $291.3M
- Size standard
- 1,250 employees
What this NAICS covers
NAICS 325413 covers manufacturing in-vitro diagnostic reagents, kits, controls, and related assay components, including production, formulation, assembly, factory testing, packaging, labeling, and quality records for clinical and point-of-care diagnostic use.
Federal opportunities under 325413 typically involve procuring manufactured IVD materials with validated lot release, documented quality control and batch records, stability and performance testing support, packaging and labeling compliance, and supply continuity for clinical and laboratory testing programs.
FY2025 snapshot
- Obligations
- $174.2M
- Awards
- 1,692
- Average award
- $103K
- Change from FY2024
- -16.4%
Federal obligation trend
FY2021
$591.9M · 726 awards
FY2022
$5.2B · 2,006 awards
FY2023
$1.9B · 1,975 awards
FY2024
$208.5M · 1,764 awards
FY2025
$174.2M · 1,692 awards
FY2026
$122.1M · 779 awards
Recent awards
$33,607
BIOMERIEUX INC
Department of Veterans Affairs
- PIID
- 36C24926N0572
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$191,530
BIOMERIEUX INC
Department of Veterans Affairs
- PIID
- 36C24926N0573
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$0
ASCENSIA DIABETES CARE US INC
Department of Veterans Affairs
- PIID
- 36C25726F0091
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$165,286
BIOMERIEUX INC
Department of Veterans Affairs
- PIID
- 36C24626N0749
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$52,224
TOSOH BIOSCIENCE, INC.
Department of Veterans Affairs
- PIID
- 36C26226N0666
- PSC
- Q301 - MEDICAL- LABORATORY TESTING
$90,847
ILLUMINA, INC.
Food and Drug Administration
- PIID
- 75F40126F19071
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$21,300
BECTON, DICKINSON AND COMPANY
Department of Veterans Affairs
- PIID
- 36C25226N0438
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
FAQ
What work fits NAICS 325413?
- Contract manufacturing of diagnostic reagent kits with batch documentation and packaging for distribution to testing laboratories.
- Production and supply of quality control materials and controls used by diagnostic laboratories for assay verification and lot-to-lot consistency.
- Scale-up manufacture of assay components and reagents to support validation runs and operational testing programs.
- Contracted manufacturing and release testing of molecular assay reagents with validated processes and retained batch records.
When is NAICS 325413 a weak fit?
- Clinical laboratory testing services: scope missing patient specimen testing, diagnostic reporting, and clinical interpretation that are core to clinical laboratory operations.
- Research reagent supply for R&D use only: missing final product release for diagnostic use and manufacturing controls tied to diagnostic supply chains.
- Medical device or instrument manufacture: missing hardware assembly, mechanical calibration, and device software integration required for instrument production.
What solicitation language points to NAICS 325413?
- Statement of work requires documented batch records, lot traceability, and retention of manufacturing documentation for each production run.
- Deliverables include stability study results, certificate of analysis for each lot, and validated manufacturing procedures or method validation reports.
- Evaluation references experience producing diagnostic reagents, manufacturing under regulated quality systems, and supplying finished reagent kits with packaging and labeling controls.
Put this market knowledge to work
Now that you know about NAICS 325413 - In-Vitro Diagnostic Substance Manufacturing, let Sweetspot help you find and win relevant government contracts with AI-powered tools.