Product code SEI— Microbiology

Access anti-HBc IgM

Classification name: Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Device class: Class 2
Regulation: 21 CFR 866.3173
Advisory panel: Microbiology
Total cleared: 4
First cleared: 2026-02-19
Most recent: 2026-04-07

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code SEI under 21 CFR 866.3173, via openFDA

Market context for product code SEI

FDA has cleared 4 devices under product code SEI, all in 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEI

Roche Diagnostics2 clearances
Beckman Coulter, Inc.2 clearances

Recent clearances under product code SEI

K260046 — Elecsys Anti-HBc IIRoche Diagnostics·2026-04-07
K260049 — Elecsys Anti-HBc IgMRoche Diagnostics·2026-04-07
K254059 — Access anti-HBc IgMBeckman Coulter, Inc.·2026-03-13
K253687 — Access anti-HBc TotalBeckman Coulter, Inc.·2026-02-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.