Gen-Probe Incorporated
Country not established
- Devices
- 4
What Gen-Probe Incorporated makes
Gen-Probe Incorporated develops molecular diagnostic assays for infectious disease testing and cancer risk assessment. Their products include nucleic acid amplification tests for detecting *Trichomonas vaginalis*, human papillomavirus (HPV) genotypes, and HPV presence, as well as a urine-based assay for prostate cancer risk evaluation using PCA3 gene expression levels.
The company’s portfolio comprises devices regulated as Class II and Class III under US FDA requirements, with authorisations granted through 510(k) clearances and Premarket Approval Applications (PMA). These products are listed in the FDA’s regulatory databases and are manufactured in the United States.
Catalogue
Aptima Trichomonas Vaginalis Assay Ref DEN110012
Regimes: De Novo Registry: De NovoProgensa PCA3 Assay Ref P100033
Regimes: PMA, withdrawn Registry: PMAAptima Hpv 16 18/45 Genotype Assay Ref P120007
Regimes: CE IVDR PMA Registry: EUDAMEDPMAGUDIDAptima Hpv Assay Ref P100042
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Gen-Probe Incorporated have in the registry?
The registry currently lists 4 devices for Gen-Probe Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gen-Probe Incorporated's devices?
Among its 4 most recently registered devices, Gen-Probe Incorporated has devices listed in EUDAMED (1 device), FDA 510(k) (1 device), FDA PMA (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gen-Probe Incorporated's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gen-Probe Incorporated's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Gen-Probe Incorporated in the registry?
The most recently registered devices listed for Gen-Probe Incorporated include APTIMA TRICHOMONAS VAGINALIS ASSAY, Progensa PCA3 Assay, APTIMA HPV 16 18/45 GENOTYPE ASSAY and APTIMA HPV ASSAY.