← Product Code [PVQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PVQ) · K170940

# Rickettsia Real-time PCR Assay (K170940)

_Centers For Disease Control and Prevention (CDC) · PVQ · Jun 29, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PVQ/K170940

## Device Facts

- **Applicant:** Centers For Disease Control and Prevention (CDC)
- **Product Code:** [PVQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PVQ.md)
- **Decision Date:** Jun 29, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3316
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PVQ/K170940](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PVQ/K170940)

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