Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3315](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3315) → PBK — Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

# PBK · Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

_Microbiology · 21 CFR 866.3315 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK

## Overview

- **Product Code:** PBK
- **Device Name:** Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- **Regulation:** [21 CFR 866.3315](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3315)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

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

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K222558](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/K222558.md) | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Aug 30, 2022 | SESE |
| [K221834](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/K221834.md) | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Jun 24, 2022 | SESE |
| [K221658](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/K221658.md) | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Jun 10, 2022 | SESE |
| [DEN070001](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/DEN070001.md) | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | Sep 21, 2018 | DENG |
| [K181205](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/K181205.md) | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Sep 20, 2018 | SESE |

## Top Applicants

- Centers for Disease Control and Prevention — 5 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK)

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