Data / Medical devices / Antigen, Cf, (Including Cf Control), Varicella-Zoster
Antigen, Cf, (Including Cf Control), Varicella-Zoster (GQW): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Antigen, Cf, (Including Cf Control), Varicella-Zoster (product code GQW, Class 2, 21 CFR 866.3900). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on August 30, 2007, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GQW
- Device class
- 2
- Regulation
- 866.3900
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Antigen, Cf, (Including Cf Control), Varicella-Zoster
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 |
|---|---|---|---|---|---|---|---|---|
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | October 24, 1989 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | April 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | August 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Viro Research LLC | Snellville, GA, United States | Manufacturer | 1 | December 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | April 19, 1985 | 0 | 0 | 0 | api.fda.gov |
Updated August 30, 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.