Data / Medical devices / Media, Potentiating For In Vitro Diagnostic Use / United States
FDA-registered makers of Media, Potentiating For In Vitro Diagnostic Use in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Media, Potentiating For In Vitro Diagnostic Use (product code KSG). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Media, Potentiating For In Vitro Diagnostic Use
- Product code
- KSG
- Country
- United States
Makers of Media, Potentiating For In Vitro Diagnostic Use in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Immucor, Inc. | Norcross, GA, United States | Manufacturer | 1 | June 15, 1979 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Raritan, NJ, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | October 11, 1979 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | October 11, 1979 | 0 | 0 | 0 | api.fda.gov |
| American Red Cross Diagnostic Manufacturing Divisi | Gaithersburg, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hemo Bioscience | Durham, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.