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
$26.4B
Total awards
90,077 awards
Active obligations
$581.4M
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.

FY2026 snapshot

Obligations
$154.2M
Awards
1,177
Average award
$131K
Change from FY2025
-9.8%

Recent awards

Search contractors

$24,980

10X GENOMICS, INC.

National Institutes of Health

PIID
75N98026F90033
PSC
6640 - LABORATORY EQUIPMENT AND SUPPLIES

$199,330

10X GENOMICS, INC.

Department of Veterans Affairs

PIID
36C24126N0993
PSC
6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS

$47,769

PROMEGA CORPORATION

National Institutes of Health

PIID
75N98026P01810
PSC
6505 - DRUGS AND BIOLOGICALS

$20,028

FISHER SCIENTIFIC COMPANY L.L.C.

Department of Veterans Affairs

PIID
36C25026P1145
PSC
6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS

$773,691

FISHER SCIENTIFIC COMPANY L.L.C.

Department of Veterans Affairs

PIID
36C25926N0509
PSC
6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS

$61,099

DERRAH MORRISON ENTERPRISES LLC

Department of Veterans Affairs

PIID
36C77026P0134
PSC
6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

$23,175

WERFEN USA LLC

National Institutes of Health

PIID
75N98026P01857
PSC
7A20 - IT AND TELECOM - APPLICATION DEVELOPMENT SOFTWARE (PERPETUAL LICENSE SOFTWARE)

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.

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