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Prognostic Test For Assessment Of Liver Related Disease Progression

QQB · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1622

Classification

FDA Product Code
QQB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1622
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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 data

Cleared 510(k) submissions
1
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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