MKT — Hepatitis Viral B Dna Detection Class II
Classification Details
- Product Code
- MKT
- Device Class
- Class II
- Regulation Number
- 866.3174
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.