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Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users is a medical device type in the Microbiology 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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Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SBZ

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Class 2

21 CFR 866.3986

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Microbiology

Device Characteristics

No

No

No

Eligible

Definition

Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is intended to aid in diagnosis of syphilis and intended for prescription use or over-the-counter use.