Data / Medical devices / Media, Potentiating For In Vitro Diagnostic Use
Media, Potentiating For In Vitro Diagnostic Use (KSG): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Media, Potentiating For In Vitro Diagnostic Use (product code KSG, Class 2, 21 CFR 864.9600). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 23, 1981, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSG
- Device class
- 2
- Regulation
- 864.9600
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| United Kingdom | 1 |
| Germany | 1 |
| France | 1 |
Makers of Media, Potentiating For In Vitro Diagnostic Use
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Alba Bioscience Limited | PENICUIK Midlothian, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Red Cross Diagnostic Manufacturing Divisi | Gaithersburg, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Medical Diagnostics GMBH | DREIEICH Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagast | LOOS Hauts-de-France, France | 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 October 23, 1981. 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.