Elsohly Labs, Inc.
United Statesfrom the FDA registration address FDA FEI 1000521247
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Elsohly Labs, Inc. makes
Elsohly Labs, Inc. manufactures ELI Urine Controls, which are diagnostic control materials used for validating urine analysis tests in clinical laboratories.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Eli Urine Controls Ref K951817
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000521247
- Address
- 5 INDUSTRIAL PARK DR., OXFORD, MS, 38655
Frequently asked questions
How many devices does Elsohly Labs, Inc. have in the registry?
The registry currently lists 1 device for Elsohly Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elsohly Labs, Inc.'s devices?
Among its 1 most recently registered device, Elsohly Labs, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Elsohly Labs, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Elsohly Labs, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Elsohly Labs, Inc. in the registry?
The most recently registered devices listed for Elsohly Labs, Inc. include ELI URINE CONTROLS.