Definitive Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Definitive Diagnostics, Inc. makes
Definitive Diagnostics, Inc. manufactures the BITEK™ Blood Culture System, a device designed for the detection and monitoring of bloodstream infections by culturing and analyzing blood samples.
The BITEK™ Blood Culture System is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Bitek(Tm) Blood Culture System Ref K875273
Regimes: 510(k) Registry: 510(k)Bitek(Tm) Blood Culture System Ref K875259
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Definitive Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Definitive Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Definitive Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Definitive Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Definitive Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Definitive Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Definitive Diagnostics, Inc. in the registry?
The most recently registered devices listed for Definitive Diagnostics, Inc. include BITEK(TM) BLOOD CULTURE SYSTEM.