QSE
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- AlzheimerS Disease Pathology Assessment Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5840
- Medical specialty
- Immunology
- FDA definition
- In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.
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| Record | Firm | Date |
|---|---|---|
| Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348) | Roche Diagnostics | 2023-06-05 |
| Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (K221842) | Roche Diagnostics | 2022-12-07 |
| Lumipulse G ß-Amyloid Ratio (1-42/1-40) (DEN200072) | Fujirebio Diagnostics,Inc. | 2022-05-04 |
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Every clearance here is in the API, with alerts when new ones post.