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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeSBZ
Regulation Number 866.3986
Device Class 2


Premarket Reviews
ManufacturerDecision
NOWDIAGNOSTICS
  GRANTED 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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