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..
List of Qualitative And Quantitative Hepatitis B Virus Antibody Assays devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Qualitative And Quantitative Hepatitis B Virus Antibody Assays devices (product code SEI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →