Access Bio, Inc.
United StatesFDA applicant, unverified FDA FEI 3024756665
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
Search and filter all 14 devicesCompany details
- FDA FEI number
- 3024756665
- DUNS number
- 116671434
- Address
- 7 Fitzgerald Ave, Monroe Township, NJ, 08831
Frequently asked questions
How many devices does Access Bio, Inc. have in the registry?
The registry currently lists 14 devices for Access Bio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Access Bio, Inc.'s devices?
Among its 14 most recently registered devices, Access Bio, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Access Bio, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Access Bio, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Access Bio, Inc. in the registry?
The most recently registered devices listed for Access Bio, Inc. include CareSuperb COVID-19/FluA&B Antigen Combo Test RCNM-02071, CareSuperb COVID-19 Antigen Test RCXM-02071, CareSuperb COVID-19 Antigen External Control SCXM-00171 and CareSuperb COVID-19 Antigen Home Test RCTM-00171.