← Product Code [QVR](/productcode/QVR) · K261362

# Xpert Hemorrhagic Fever (K261362)

_Cepheid · QVR · Aug 7, 2026 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261362

## Device Facts

- **Applicant:** Cepheid
- **Product Code:** [QVR](/productcode/QVR.md)
- **Decision Date:** Aug 7, 2026
- **Decision:** SESE
- **Submission Type:** Dual Track
- **Regulation:** 21 CFR 866.4000
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

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**Source:** [https://fda.innolitics.com/device/K261362](https://fda.innolitics.com/device/K261362)

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