Hologic / Gen-Probe Incorporated
Country not established
- Devices
- 1
What Hologic / Gen-Probe Incorporated makes
Hologic/Gen-Probe Incorporated manufactures molecular diagnostic assays, including the APTIMA COMBO 2 ASSAY, which detects multiple pathogens using the PANTHER automated system for laboratory testing.
The company’s products fall under FDA Class II devices and are authorised via 510(k) clearance. The portfolio is regulated under US medical device laws, with listings maintained in the FDA’s 510(k) database.
Catalogue
Aptima Combo 2 Assay (Panther System) Ref K132251
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hologic / Gen-Probe Incorporated have in the registry?
The registry currently lists 1 device for Hologic / Gen-Probe Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hologic / Gen-Probe Incorporated's devices?
Among its 1 most recently registered device, Hologic / Gen-Probe Incorporated has devices listed in FDA 510(k) (1 device).
What risk classes do Hologic / Gen-Probe Incorporated's devices fall under?
Among its 1 most recently registered device, the classes recorded for Hologic / Gen-Probe Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hologic / Gen-Probe Incorporated in the registry?
The most recently registered devices listed for Hologic / Gen-Probe Incorporated include APTIMA COMBO 2 ASSAY (PANTHER SYSTEM).