Data / Medical devices / Plasma, Control, Normal / United States
FDA-registered makers of Plasma, Control, Normal in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Plasma, Control, Normal (product code GIZ). 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
- Plasma, Control, Normal
- Product code
- GIZ
- Country
- United States
Makers of Plasma, Control, Normal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | December 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Manufacturer for export | 1 | October 7, 1994 | 0 | 0 | 0 | api.fda.gov |
| George King Bio-Medical, Inc. | Overland Park, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, 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.