Data / Medical devices / System, Test, Infectious Mononucleosis / United States
FDA-registered makers of System, Test, Infectious Mononucleosis in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make System, Test, Infectious Mononucleosis (product code KTN). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, Test, Infectious Mononucleosis
- Product code
- KTN
- Country
- United States
Makers of System, Test, Infectious Mononucleosis in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 2 | June 28, 1990 | 0 | 1 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 2 | January 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Arlington Scientific, Inc. | Springville, UT, United States | Contract manufacturer, Manufacturer | 1 | July 2, 1982 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 1 | February 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Cenogenics Corp. | Morganville, NJ, United States | Manufacturer | 1 | August 21, 1989 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | February 28, 2005 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | December 14, 1987 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | February 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | February 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | February 4, 1997 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | June 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.