Alamar Biosciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Alamar Biosciences, Inc. makes
Alamar Biosciences, Inc. manufactures antimicrobial susceptibility test panels and devices, including Gram-negative panels, microdilution systems for detecting high-level aminoglycoside resistance, and automated susceptibility readers like the READAR. Their products are designed for laboratory use to identify bacterial resistance patterns to antibiotics, aiding in targeted antimicrobial therapy.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) pathway. These devices are listed under the FDA’s regulatory framework and are intended for use in clinical microbiology laboratories in the United States.
Catalogue
Readar/Susceptibility, Gram Negative Panels Ref K925859
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Readar Ref K930478
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alamar Biosciences, Inc. have in the registry?
The registry currently lists 5 devices for Alamar Biosciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alamar Biosciences, Inc.'s devices?
Among its 5 most recently registered devices, Alamar Biosciences, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Alamar Biosciences, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Alamar Biosciences, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alamar Biosciences, Inc. in the registry?
The most recently registered devices listed for Alamar Biosciences, Inc. include READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS, ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION, MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE and READAR.