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510(k) K241110

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) by Centers For Disease Control and Prevention — Product Code OZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2024
Date Received
April 22, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.

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  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (August 30, 2022)
  • K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 24, 2022)
  • K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 10, 2022)
  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
  • K192871 — B. anthracis Real-time PCR Assay (November 7, 2019)
  • K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)
  • DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (September 21, 2018)

Other clearances for product code OZE

  • K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin (July 11, 2025)
  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K230236 — Lyra Influenza A+B Assay (March 3, 2023)
  • K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (June 24, 2022)
  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
  • K182513 — FluChip-8G Influenza A+B Assay (April 22, 2019)
  • K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)
  • K190204 — ID NOW Influenza A & B 2 (March 18, 2019)
  • K181736 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage (July 30, 2018)
  • K171641 — Accula Flu A/Flu B Test (February 6, 2018)