Affinity Biosensors
Country not established FDA establishment FEI 3025772277
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
What Affinity Biosensors makes
Affinity Biosensors produces automated antimicrobial susceptibility testing (AST) systems paired with Gram-negative bacterial identification kits, designed for microbiology laboratories to streamline pathogen identification and antibiotic resistance profiling.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- 510(k) 510(k)
- 510(k) 510(k)
- 510(k) 510(k)
Company details
- FDA FEI number
- 3025772277
- Address
- 222 E Canon Perdido St Ste 101, Santa Barbara, CA, 93101
Frequently asked questions
How many devices does AFFINITY BIOSENSORS have in the registry?
The registry currently lists 6 devices for AFFINITY BIOSENSORS. Devices recorded under merged duplicate company entries are counted once.
Which registries list AFFINITY BIOSENSORS's devices?
Among its 6 most recently registered devices, AFFINITY BIOSENSORS has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do AFFINITY BIOSENSORS's devices fall under?
Among its 6 most recently registered devices, the classes recorded for AFFINITY BIOSENSORS's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from AFFINITY BIOSENSORS in the registry?
The most recently registered devices listed for AFFINITY BIOSENSORS include LifeScale AST 3010-0000, LifeScale Sensor LS6501, LSGN LS6503 and LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system.