Henage Diagnostics, Inc.
Country not established
- Devices
- 1
What Henage Diagnostics, Inc. makes
Henage Diagnostics, Inc. manufactures the RAICHEM Rheumatoid Factor SPIA, a diagnostic test designed to detect rheumatoid factor antibodies in patient samples, aiding in the diagnosis of rheumatoid arthritis.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The product is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Raichem Rheumatoid Factor Spia Ref K970373
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Henage Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Henage Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Henage Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Henage Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Henage Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Henage Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Henage Diagnostics, Inc. in the registry?
The most recently registered devices listed for Henage Diagnostics, Inc. include RAICHEM RHEUMATOID FACTOR SPIA.