Digene Diagnostics, Inc.
Country not established
- Devices
- 1
What Digene Diagnostics, Inc. makes
Digene Diagnostics, Inc. manufactures the DIGENE DCR-1 LUMINOMETER, a device used for measuring luminescence in clinical diagnostics, typically for assays like HPV testing.
The DCR-1 LUMINOMETER 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
Digene Dcr-1 Luminometer Ref K940486
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digene Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Digene Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Digene Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Digene Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Digene Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Digene Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Digene Diagnostics, Inc. in the registry?
The most recently registered devices listed for Digene Diagnostics, Inc. include DIGENE DCR-1 LUMINOMETER.