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Prognostic Test For Assessment Of Liver Related Disease Progression

Prognostic Test For Assessment Of Liver Related Disease Progression is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Prognostic Test For Assessment Of Liver Related Disease Progression
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QQB

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Class 2

21 CFR 862.1622

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Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

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.