FDA.reportPublic FDA data

Hepatitis B virus surface antigen IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen.
GUDID devices
7
Last updated
2026-01-26 16:10:19

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
15099590806279Access HBsAg CALIBRATORBeckman Coulter, Inc.D229152026-01-16
00380740203214AlinityABBOTT LABORATORIES06P02062025-09-24
00380740214296AlinityAbbott Ireland Diagnostics01R64022024-06-28
00380740208486ARCHITECTAbbott Ireland Diagnostics4P76-022023-04-13
00380740146238AlinityAbbott Ireland Diagnostics08P10022020-07-10
00380740136772AlinityAbbott Ireland Diagnostics06P02042019-09-14
00380740007751ARCHITECTAbbott Ireland Diagnostics4P53-012014-11-18