Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
The Non-Variola Orthopoxvirus Real-Time PCR Primer and Probe Set is a microbiology in vitro diagnostic device for the qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3315, requiring 510(k) premarket notification. This type of assay is used in public health surveillance and clinical diagnostics to identify orthopoxvirus infections (such as monkeypox) other than smallpox. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PBK
- Device Class
- FDA class 2
- Regulation Number
- 866.3315
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Aug 30, 2022 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Jun 24, 2022 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Jun 10, 2022 | Substantially Equivalent | Centers for Disease Control and Prevention |
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Sep 21, 2018 | Unknown | Centers for Disease Control and Prevention |
| K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Sep 20, 2018 | Substantially Equivalent | Centers for Disease Control and Prevention |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.