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Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA product code SEI · 4 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3173
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-02-19 – 2026-04-07

In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.

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