Data / Medical devices / Antigens, Cf (Including Cf Control), Adenovirus 1-33
Antigens, Cf (Including Cf Control), Adenovirus 1-33 (GOD): 17 FDA-registered makers in 6 countries
17 establishments in 6 countries are registered with the FDA to make Antigens, Cf (Including Cf Control), Adenovirus 1-33 (product code GOD, Class 1, 21 CFR 866.3020). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on May 17, 2011, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- GOD
- Device class
- 1
- Regulation
- 866.3020
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Italy | 1 |
| Germany | 1 |
| Mexico | 1 |
| China | 1 |
| Taiwan | 1 |
Makers of Antigens, Cf (Including Cf Control), Adenovirus 1-33
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 |
|---|---|---|---|---|---|---|---|---|
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | July 8, 1988 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 1 | May 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | May 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 1 | May 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Aalto Scientific Ltd. | Eatonton, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diesse Diagnostica Senese S.P.A | MONTERIGGIONI Siena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panion & BF Biotech Inc. Xizhi Second Factory | New Taipei City, Taiwan | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SA Scientific, Ltd | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 17, 2011. 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.