$125,000
DIASORIN INC
Department of Veterans Affairs
- PIID
- 36C26026N0382
- PSC
- Q301 - MEDICAL- LABORATORY TESTING
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
- 42,938 awards
- Active obligations
- $297.7M
- 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
- $173.7M
- Awards
- 1,692
- Average award
- $102.7K
- Change from FY2024
- -16.2%
Federal obligation trend
FY2021
$499.8M · 524 awards
FY2022
$5.2B · 2,006 awards
FY2023
$1.9B · 1,975 awards
FY2024
$207.2M · 1,763 awards
FY2025
$173.7M · 1,692 awards
FY2026
$134.9M · 928 awards
Recent awards
$28,264
FISHER SCIENTIFIC COMPANY L.L.C.
Department of Veterans Affairs
- PIID
- 36C25226N0484
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$24,917
STRIPES GLOBAL, INC.
Department of Veterans Affairs
- PIID
- 36C26026P0582
- PSC
- 6640 - LABORATORY EQUIPMENT AND SUPPLIES
$93,253
QIAGEN, LLC
Department of Veterans Affairs
- PIID
- 36C25526N0349
- PSC
- 6640 - LABORATORY EQUIPMENT AND SUPPLIES
$52,965
REMEL INC.
Food and Drug Administration
- PIID
- 75F40126F19020
- PSC
- 6640 - LABORATORY EQUIPMENT AND SUPPLIES
$421,282
BIOMERIEUX INC
Department of Veterans Affairs
- PIID
- 36C25026N0572
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$3,060,000
VMRD INC
Animal and Plant Health Inspection Service
- PIID
- 12639526F0624
- PSC
- 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
$143,975
ILLUMINA, INC.
Food and Drug Administration
- PIID
- 75F40126F19075
- 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.