QQB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1622
- Medical specialty
- Clinical Chemistry
- FDA definition
- prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.
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| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Enhanced Liver Fibrosis (ELF) (DEN190056) | Siemens Healthcare Diagnostics, Inc. | 2021-08-20 |
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Every clearance here is in the API, with alerts when new ones post.