FDA.reportPublic FDA data

Alpha-fetoprotein (AFP) 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 alpha-fetoprotein (AFP) in a clinical specimen.
GUDID devices
61
Last updated
2026-06-16 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405002177Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob1292026-06-05
00846405002184Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob129-052026-06-05
00846405002191Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob129-012026-06-05
00846405006281Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0572026-06-05
00846405007448Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR0132026-06-05
00846405010806Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP0012026-06-05
00846405010813Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP001-052026-06-05
00846405010820Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP001-012026-06-05
00846405018673Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM057-HL2026-06-05
00846405019700Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM057-10MM2026-06-05
00846405020768Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDR013-S2026-06-05
00846405020805Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM057-S2026-06-05
00846405025640Diagnostic BioSystemsDiagnostic Biosystems, Inc.RP001-BLK2026-06-05
05055331335548BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0963-U2022-12-16
00810170552274IHCSlmp, LLC(BTO) Sample α Fetoprotein - AFP (C3) Antibody (2m2025-03-07
00810170550195IHCSlmp, LLC(BTO) α Fetoprotein - AFP (C3) Antibody (10ml)2025-03-03
00810170550201IHCSlmp, LLC(BTO) Manual α Fetoprotein - AFP (C3) Antibody (6m2025-03-03
B502BSB23840Tinto Alpha-Fetoprotein RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB23850Tinto Alpha-Fetoprotein, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB23860Tinto Alpha-Fetoprotein, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB23870Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB23880Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB23890Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB50500Tinto Alpha-Fetoprotein, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB50510Tinto Alpha-Fetoprotein, MMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB50520Tinto Alpha-Fetoprotein, MMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB50530Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB50540Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB50550Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
05055331324108NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDAFP-L-U2023-07-28
00810113064369Rabbit Monoclonal Anti-Human AFP Antibody, EP209Epitomics Inc.AC-0166A2023-06-12
00810113064376Rabbit Monoclonal Anti-Human AFP Antibody, EP209Epitomics Inc.AC-01662023-06-12
00810113064383Rabbit Monoclonal Anti-Human AFP Antibody, EP209Epitomics Inc.AC-0166B2023-06-12
00810113064390Rabbit Monoclonal Anti-Human AFP Antibody, EP209Epitomics Inc.AC-0166BULK2023-06-12
00810119675309ANTI-AFPBIOGENEX LABORATORIESMU008A-UC2023-05-05
00847627007803AFPBIOCARE MEDICAL LLCCP028A2022-12-07
00847627012081AFPBIOCARE MEDICAL LLCPP028AA2022-12-07
05055331303714BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA09632022-12-07
05055331326447Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDAFP-L-CE2022-12-07
00841683125921Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION203R-142022-11-14
00841683125938Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION203R-152022-11-14
00841683125945Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION203R-162022-11-14
00841683125952Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION203R-172022-11-14
00841683125969Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION203R-182022-11-14
00841683100010Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION760-26032021-04-15
00841683125877Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION203A-142020-12-07
00841683125884Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION203A-152020-12-07
00841683125891Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION203A-162020-12-07
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinAGILENT TECHNOLOGIES SINGAPORE PTE LTDA00082020-09-17
05700572029359FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR5002020-09-17
05700572029656FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS5002020-09-17
05700572034049FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA5002020-09-17
00841683125907Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION203A-172020-09-15
00841683125914Alpha-Fetoprotein Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION203A-182020-09-15
00615233006325Genemed®SAKURA FINETEK U.S.A., INC.60-0088-72019-12-28
L502BSB2387Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB2388Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB2389Alpha-Fetoprotein RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
L502BSB5053Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB5054Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB5055Alpha-Fetoprotein MMabBIO SB, INC.Concentrate, 1 ml2020-03-16