Qualitative And Quantitative Hepatitis B Virus Antibody Assays
SEI · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3173
Classification
FDA Product Code
SEI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3173
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.