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.