Product code OYB
- Device name
- Kit, Rna Detection, Human Papillomavirus
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P120007S034 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2026-02-03 |
| P100042S038 | APTIMA HPV ASSAY | Gen-Probe Incorporated | 2026-02-03 |
| P120007S033 | Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass | Gen-Probe Incorporated | 2025-10-07 |
| P100042S039 | Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A | Gen-Probe Incorporated | 2025-10-07 |
| P120007S032 | Aptima HPV-GT Assay | Gen-Probe Incorporated | 2024-10-23 |
| P100042S037 | Aptima HPV Assay | Gen-Probe Incorporated | 2024-10-23 |
| P120007S031 | Aptima HPV-GT Assay | Gen-Probe Incorporated | 2024-07-26 |
| P100042S036 | Aptima HPV Assay | Gen-Probe Incorporated | 2024-07-26 |
| P100042S035 | Aptima HPV Assay | Gen-Probe Incorporated | 2023-07-07 |
| P120007S030 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2023-06-02 |
| P100042S034 | Aptima HPV Assay | Gen-Probe Incorporated | 2023-06-02 |
| P120007S029 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2022-02-25 |
| P100042S032 | Aptima HPV Assay | Gen-Probe Incorporated | 2022-02-25 |
| P100042S033 | Aptima HPV Assay | Gen-Probe Incorporated | 2022-01-28 |
| P120007S028 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2020-07-21 |
| P100042S031 | Aptima HPV Assay | Gen-Probe Incorporated | 2020-07-21 |
| P120007S027 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2020-06-11 |
| P100042S030 | Aptima HPV Assay | Gen-Probe Incorporated | 2020-06-11 |
| P120007S025 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2020-04-27 |
| P100042S027 | Aptima HPV Assay | Gen-Probe Incorporated | 2020-04-27 |
| P100042S029 | Aptima HPV Assay | Gen-Probe Incorporated | 2020-02-10 |
| P120007S026 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2020-01-21 |
| P100042S028 | Aptima HPV Assay | Gen-Probe Incorporated | 2020-01-21 |
| P120007S022 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2019-12-16 |
| P100042S024 | Aptima HPV Assay | Gen-Probe Incorporated | 2019-12-16 |
| P120007S024 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2019-09-16 |
| P100042S026 | Aptima HPV Assay | Gen-Probe Incorporated | 2019-09-16 |
| P120007S023 | Aptima HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2019-08-27 |
| P100042S025 | Aptima HPV Assay | Gen-Probe Incorporated | 2019-08-27 |
| P120007S020 | APTIMA HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated | 2019-04-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15420045500051 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500068 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500075 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500082 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500099 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500105 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500112 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500129 | Aptima® | Hologic, Inc. | 2014-07-30 |
| 15420045500136 | Aptima® | Hologic, Inc. | 2014-07-30 |