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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device zika virus serological reagents
Definition Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
Product CodeQFO
Regulation Number 866.3935
Device Class 2


Premarket Reviews
ManufacturerDecision
CHEMBIO DIAGNOSTIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
INBIOS INTERNATIONAL, INC.
  GRANTED 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

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