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510(k) DEN070001

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET by Centers For Disease Control and Prevention — Product Code PBK

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 21, 2018
Date Received
January 16, 2007
Clearance Type
Post-NSE
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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  • 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)
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Other clearances for product code PBK

  • 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)
  • K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (September 20, 2018)