← Product Code [PBK](/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK) · DEN070001

# NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001)

_Centers for Disease Control and Prevention · PBK · Sep 21, 2018 · Microbiology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/DEN070001

## Device Facts

- **Applicant:** Centers for Disease Control and Prevention
- **Product Code:** [PBK](/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK.md)
- **Decision Date:** Sep 21, 2018
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 866.3315
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

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

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/DEN070001](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PBK/DEN070001)

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