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510(k) K222558

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set by Centers For Disease Control and Prevention — Product Code PBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2022
Date Received
August 24, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Device Class
Class II
Regulation Number
866.3315
Review Panel
MI
Submission Type

In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.

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  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi (May 21, 2024)
  • 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 PBK

  • 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)
  • DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (September 21, 2018)
  • K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (September 20, 2018)