Data / Medical devices / System, Test, Infectious Mononucleosis
System, Test, Infectious Mononucleosis (KTN): 18 FDA-registered makers in 4 countries
18 establishments in 4 countries are registered with the FDA to make System, Test, Infectious Mononucleosis (product code KTN, Class 2, 21 CFR 866.5640). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 59 510(k) clearances under this code, the latest on June 22, 2018, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KTN
- Device class
- 2
- Regulation
- 866.5640
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Mexico | 2 |
| Spain | 1 |
| United Kingdom | 1 |
Makers of System, Test, Infectious Mononucleosis
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 1 | December 14, 1987 | 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 |
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer | 1 | April 7, 1988 | 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 | |
| Laboratorios Scantibodies S.A. De C.V. | TECATE Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Scantibodies, S.A. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 22, 2018. 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.