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FDA PRODUCT CODE · CLASS II

MKT — Hepatitis Viral B Dna Detection

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3174
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES

Recent clearances

P150014Roche Molecular Systems, Inc. · pma2025-10-17
P200013Abbott Molecular, Inc. · pma2025-10-17
P170025Hologic, Inc. · pma2025-10-07
P080026Abbott Molecular, Inc. · pma2025-04-18
P050028Roche Molecular Systems, Inc. · pma2024-10-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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