Data / Medical devices / Test System, Nicotine, Cotinine, Metabolites / United States
FDA-registered makers of Test System, Nicotine, Cotinine, Metabolites in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Test System, Nicotine, Cotinine, Metabolites (product code MRS). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Test System, Nicotine, Cotinine, Metabolites
- Product code
- MRS
- Country
- United States
Makers of Test System, Nicotine, Cotinine, Metabolites in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mossman Associates, Inc. | Milford, MA, United States | Manufacturer, Specification developer | 1 | December 13, 1996 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 1 | May 22, 2003 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advin Biotech, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| CorDx, Inc. | Alpharetta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Biotech, LLC | Minneapolis, MN, United States | Complaint file establishment, Specification developer | 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.