# Bacteriophage And Controls, B. Anthracis Lysis
> **Product code: NVQ** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3045
## Classification
- **FDA Product Code:** NVQ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3045
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar.  To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NVQ)
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