Data / Medical devices / Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Respiratory Syncytial Virus, Antigen, Antibody, Ifa (LKT): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Respiratory Syncytial Virus, Antigen, Antibody, Ifa (product code LKT, Class 1, 21 CFR 866.3480). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on December 23, 2008, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LKT
- Device class
- 1
- Regulation
- 866.3480
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 1 |
Makers of Respiratory Syncytial Virus, Antigen, Antibody, Ifa
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 |
|---|---|---|---|---|---|---|---|---|
| Remel Europe Ltd | Dartford, Kent, United Kingdom | Contract manufacturer, Manufacturer, Specification developer | 2 | March 18, 1999 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | October 16, 1989 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | August 11, 1983 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | December 23, 2008 | 0 | 0 | 0 | api.fda.gov |
Updated December 23, 2008. 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.