Hepatitis Viral B Dna Detection
The Hepatitis B Viral DNA Detection device is an in vitro nucleic acid amplification assay used to detect and quantify Hepatitis B Virus (HBV) DNA in patient blood specimens, providing critical diagnostic information for confirming active HBV infection, assessing viral load, guiding antiviral therapy decisions, and monitoring treatment response. As a Class 3 device, it requires Premarket Approval (PMA) reflecting the high regulatory standards applied to nucleic acid tests used in the management of serious viral infections. No regulation number or medical specialty code is assigned in the classification database.
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Basic Information
- Product Code
- MKT
- Device Class
- FDA class 2
- Regulation Number
- 866.3174
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.