# Hepatitis Viral B Dna Detection
> **Product code: MKT** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3174
## Classification
- **FDA Product Code:** MKT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3174
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment.  The test results must be interpreted within the context of all relevant clinical and laboratory findings.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=MKT)
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