Data / Medical devices / Device, Specimen Collection / United States
FDA-registered makers of Device, Specimen Collection in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Device, Specimen Collection (product code LIO). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Device, Specimen Collection
- Product code
- LIO
- Country
- United States
Makers of Device, Specimen Collection 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 | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | April 3, 1996 | 0 | 1 | 0 | api.fda.gov |
| Apex Medical Technologies, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | March 18, 1993 | 0 | 0 | 0 | api.fda.gov |
| Arx Sciences | Amherst, NY, United States | Manufacturer | 1 | March 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson Caribe Ltd. | Cayey, PR, United States | Manufacturer | 1 | July 30, 1992 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 1 | July 30, 1992 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 1 | February 2, 1990 | 0 | 1 | 0 | api.fda.gov |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 1 | April 3, 1996 | 0 | 0 | 0 | api.fda.gov |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Contract manufacturer, Manufacturer | 1 | June 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| COPAN Diagnostics, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Norfolk, NE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Industries, Inc. | Aguadilla, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MML Diagnostics Packaging, Inc. | Troutdale, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer for export | 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.