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U.S. Department of Health and Human Services

Product Classification

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Device test for detection of antibodies associated with syphilis performed by lay users
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.
Physical State Plastic cassette containing nitrocellulose membrane embedded with reagents capable of identifying analyte-specific antibodies in a blood sample.
Technical Method Immobilization and visualization of antibodies specific to Syphilis disease using lateral flow technology.
Target Area Blood drop exposed on the fingertip via fingerstick puncture.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeSBZ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3986
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
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