Product code QQB— Clinical Chemistry
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- Classification name
- Prognostic Test For Assessment Of Liver Related Disease Progression
- Device class
- Class 2
- Regulation
- 21 CFR 862.1622
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
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.”
Market context for product code QQB
FDA has cleared device under product code QQB, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QQB
Recent clearances under product code QQB
Data sourced from openFDA. This site is unofficial and independent of the FDA.