QQB
- Product code
- QQB
- Device name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1622
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
Official FDA classification page: QQB
Classification and pathway per current FDA publications. Data from openFDA (CC0).