Bionostics, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000041075 FEI 1220649
- Devices
- 49
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Bionostics, Inc. makes
Bionostics, Inc. manufactures a range of in vitro diagnostic control materials, including calibration verification controls for glucose and beta‑ketone testing, hemoglobin A1c controls, blood gas control solutions, multi‑analyte controls at various concentration levels, and specific glucose meter control solutions for several manufacturers, as well as lead control materials.
These products are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) database. The company is based in the United States.
Catalogue
Search and filter all 49 devicesCompany details
- EUDAMED SRN
- US-MF-000041075
- FDA FEI number
- 1220649
- EUDAMED status
- Active
- EUDAMED registered name
- Bionostics
- Registered address
- 7, Jackson Road, 01434, Devens, United States
- [email protected]
- PRRC contact
- Yifei Wang
Frequently asked questions
How many devices does Bionostics, Inc. have in the registry?
The registry currently lists 49 devices for Bionostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionostics, Inc.'s devices?
Among its 49 most recently registered devices, Bionostics, Inc. has devices listed in FDA 510(k) (49 devices).
What risk classes do Bionostics, Inc.'s devices fall under?
Among its 49 most recently registered devices, the classes recorded for Bionostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionostics, Inc. in the registry?
The most recently registered devices listed for Bionostics, Inc. include LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION, RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS, RNA1C CONTROL FOR NYCOCARD HBA1C and FLUSH SOLUTION CONCENTRATE-BLOOD GAS.