Mk Bio, Inc.
Country not established
- Devices
- 1
What Mk Bio, Inc. makes
Mk Bio, Inc. manufactures the BIONEXIA OPTICUP, an integrated urine collection cup with a multi-strip dipstick for point-of-care diagnostic testing. The device combines sample collection and immediate analysis of key urinary metrics, including glucose, pH, protein, ketones, blood, and bilirubin.
The BIONEXIA OPTICUP is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mk Bio, Inc. have in the registry?
The registry currently lists 1 device for Mk Bio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mk Bio, Inc.'s devices?
Among its 1 most recently registered device, Mk Bio, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Mk Bio, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Mk Bio, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mk Bio, Inc. in the registry?
The most recently registered devices listed for Mk Bio, Inc. include BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP.