Data / Medical devices / Antigen, Cf (Including Cf Control), Cytomegalovirus
Antigen, Cf (Including Cf Control), Cytomegalovirus (GQH): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Antigen, Cf (Including Cf Control), Cytomegalovirus (product code GQH, Class 2, 21 CFR 866.3175). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on December 14, 1998, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GQH
- Device class
- 2
- Regulation
- 866.3175
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Antigen, Cf (Including Cf Control), Cytomegalovirus
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 |
|---|---|---|---|---|---|---|---|---|
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 2 | December 5, 1988 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | June 3, 1988 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | September 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 14, 1998. 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.