Akers Research Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Akers Research Corp. makes
Akers Research Corp. manufactures in vitro diagnostic assays for detecting specific antibodies in human serum, including rheumatoid factor, cytomegalovirus antibodies, and Epstein-Barr virus (infectious mononucleosis) markers. These tests are designed for laboratory use to aid in the diagnosis of autoimmune and infectious diseases.
The company’s portfolio consists of Class II devices, regulated under the FDA’s 510(k) premarket notification process. These assays are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Healthtest Rheumatoid Factor Assay Ref K920220
Regimes: 510(k) Registry: 510(k)Healthtest Assay For Antibody To Cytomegalovirus Ref K920222
Regimes: 510(k) Registry: 510(k)Healthtest Infectious Mononucleosis Assay Ref K920221
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Akers Research Corp. have in the registry?
The registry currently lists 3 devices for Akers Research Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Akers Research Corp.'s devices?
Among its 3 most recently registered devices, Akers Research Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Akers Research Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Akers Research Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Akers Research Corp. in the registry?
The most recently registered devices listed for Akers Research Corp. include HEALTHTEST RHEUMATOID FACTOR ASSAY, HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS and HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY.