Data / Medical devices / Antisera, All Groups, Streptococcus Spp. / United States
FDA-registered makers of Antisera, All Groups, Streptococcus Spp. in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Antisera, All Groups, Streptococcus Spp. (product code GTZ). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Antisera, All Groups, Streptococcus Spp.
- Product code
- GTZ
- Country
- United States
Makers of Antisera, All Groups, Streptococcus Spp. in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 3 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 3 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 3 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer | 2 | November 30, 2001 | 0 | 1 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 2 | November 30, 2001 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Contract manufacturer, Manufacturer | 1 | October 11, 1996 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 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.