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Immunoassay Blood Test For Amyloid Pathology Assessment

Immunoassay Blood Test For Amyloid Pathology Assessment is a medical device type in the Immunology 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.

Global Registration Data
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Immunoassay Blood Test For Amyloid Pathology Assessment
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SET

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Class 2

21 CFR 866.5840

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Immunology

Device Characteristics

No

No

No

Not Eligible

Definition

An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimerย’s Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information.