# Gen-Probe, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 68 (1985–2013): 62 510(k) clearances, 1 De Novo grant and 5 original PMA approvals
- Names in FDA's records: Gen-Probe, Inc. (63); Gen-Probe Incorporated (4); Gen-Probe (1)
- Product codes: LSL (15), LQF (13), MKZ (5), JJQ (4), LSK (4), MDK (3), OYB (2), GTZ (2), OUY (2), MCC (2), JXA (1), MDC (1)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 34 (4 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)

## Firms that cite its devices most
- Hologic, Inc.: 8 (https://510kreport.com/company/hologic)
- Becton, Dickinson & CO: 8 (https://510kreport.com/company/becton-dickinson)
- Cepheid: 4 (https://510kreport.com/company/cepheid)
- Abbott Molecular, Inc.: 4 (https://510kreport.com/company/abbott-molecular)
- Digene Corp.: 2 (https://510kreport.com/company/digene)
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)
- Hologic / Gen-Probe Incorporated: 1 (https://510kreport.com/company/hologic-gen-probe)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Its most-cited devices
- K122062: Aptima Trichomonas Vaginalis Assay - Panther (2013), cited by 5
- K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae (2005), cited by 4
- K003395: Gen-Probe Aptima Combo 2 Assay (2001), cited by 4
- DEN110012: Aptima Trichomonas Vaginalis Assay (2011), cited by 4
- K043224: Gen-Probe Aptima Combo 2 Assay (2005), cited by 3
- K062440: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091 (2006), cited by 3

## Recent decisions
- K122062: Aptima Trichomonas Vaginalis Assay - Panther (Jan 9, 2013)
- P120007: Aptima HPV 16 18/45 Genotype Assay (Oct 12, 2012)
- K111409: Aptima Combo 2 Assay (May 3, 2012)
- P100033: Progensa PCA3 Assay (Feb 13, 2012)
- P100042: Aptima HPV Assay (Oct 28, 2011)
- DEN110012: Aptima Trichomonas Vaginalis Assay (Apr 19, 2011)
- K063664: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091 (Jan 25, 2007)
- K063451: Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199 (Jan 22, 2007)

Source page: https://510kreport.com/company/gen-probe