FDA Product Code SEI: Qualitative And Quantitative Hepatitis B Virus Antibody Assays
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.
Leading manufacturers include Beckman Coulter, Inc. and Roche Diagnostics.
4
Total
4
Cleared
89d
Avg days
2026
Since
Growing category -
4 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Qualitative And Quantitative Hepatitis B Virus Antibody Assays Devices (Product Code SEI)
4 devices
Cleared
Apr 07, 2026
Elecsys Anti-HBc II
Roche Diagnostics
Microbiology
90d
Cleared
Apr 07, 2026
Elecsys Anti-HBc IgM
Roche Diagnostics
Microbiology
90d
Cleared
Mar 13, 2026
Access anti-HBc IgM
Beckman Coulter, Inc.
Microbiology
86d
Cleared
Feb 19, 2026
Access anti-HBc Total
Beckman Coulter, Inc.
Microbiology
90d
About Product Code SEI - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code SEI since 2026, with 4 receiving FDA clearance (average review time: 89 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.