Data / Medical devices / Plasma, Control, Normal
Plasma, Control, Normal (GIZ): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Plasma, Control, Normal (product code GIZ, Class 2, 21 CFR 864.5425). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on May 15, 2007, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GIZ
- Device class
- 2
- Regulation
- 864.5425
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Canada | 2 |
| France | 1 |
| Switzerland | 1 |
| Germany | 1 |
Makers of Plasma, Control, Normal
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 |
|---|---|---|---|---|---|---|---|---|
| Biomedica Diagnostics Inc. | Windsor Nova Scotia, Canada | Manufacturer | 1 | September 19, 1994 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | June 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Precision BioLogic Inc. | Dartmouth Nova Scotia, Canada | Manufacturer | 1 | December 10, 2001 | 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 | |
| Pentapharm AG | Aesch Basel-Landschaft, Switzerland | Contract 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 | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 15, 2007. 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.