510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SEIClass II

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

21 CFR 866.3173 / Microbiology
FDA source (opens on fda.gov)

SEI is the FDA product code for Qualitative And Quantitative Hepatitis B Virus Antibody Assays, a class II device type, regulated under 21 CFR 866.3173. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SEI
Device name
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA 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.
Regulation
21 CFR 866.3173
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code SEI

By decision year
4 clearances under product code SEI with a decision year between 2026 and 2026, 2026 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code SEI by decision year
YearClearances
20264

Applicants with the most clearances

Product code SEI
Applicants holding the most 510(k) clearances under product code SEI
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Roche Diagnostics GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code