Akers Biosciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Akers Biosciences, Inc. makes
Akers Biosciences, Inc. manufactures in vitro diagnostic (IVD) tests for detecting platelet factor 4-heparin complex antibodies, including rapid agglutination kits and control reagents. Their portfolio includes serum panels and rapid assay devices designed for clinical use in identifying heparin-induced thrombocytopenia (HIT) markers. They also produce breath alcohol detection systems for measuring alcohol levels in exhaled breath, including portable and detection-specific models.
The company’s diagnostic tests fall under FDA Class I and Class II regulatory categories, with alcohol detection devices listed under 510(k) and UDI requirements. Their products are registered with the FDA and comply with U.S. medical device regulations. The company is headquartered in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Modification To: Instaread Lithium System Ref K050338
Regimes: 510(k) Registry: 510(k)Breathscn Pro Ref K102338
Regimes: 510(k) Registry: 510(k)Heparin/Platelet Factor 4 Antibody Serum Panel Ref K052697
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 611245549
- [email protected]
- Phone
- 8568488698
Frequently asked questions
How many devices does Akers Biosciences, Inc. have in the registry?
The registry currently lists 9 devices for Akers Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Akers Biosciences, Inc.'s devices?
Among its 9 most recently registered devices, Akers Biosciences, Inc. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Akers Biosciences, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Akers Biosciences, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Akers Biosciences, Inc. in the registry?
The most recently registered devices listed for Akers Biosciences, Inc. include PIFA® Heparin/PF4 Rapid Assay 4036025, PIFA PLUSS® PF4 Rapid Assay 4001101, Heparin/PF4 Antibody Serum Panel 4036027 and Heparin/PF4 Antibody Serum Panel 4036028.