FDA.reportPublic FDA data

Total human chorionic gonadotropin IVD, antibody

Definition
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.
GUDID devices
11
Last updated
2026-06-17 06:05:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405007578Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0302026-06-08
00846405011469Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0072026-06-08
00846405011476Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP007-052026-06-08
00846405011483Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP007-012026-06-08
00846405018543Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR030-HL2026-06-08
00846405021895Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR030-S2026-06-08
00846405023486Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR030-252026-06-08
B502BSB55990hCG MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB56000hCG MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB56010hCG MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
10722355001446Detector Cept-D PolyclonalImmunostics Company, Inc431002016-09-20