FDA.reportPublic FDA data

Hepatocyte specific antigen 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 hepatocyte specific antigen in a clinical specimen.
GUDID devices
58
Last updated
2026-10-04 01:44:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840542222870Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESAMC47-5M2026-09-22
00840542222887Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESAMC47-10M2026-09-22
00840542222894Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESAXC47-YCD2026-09-22
00840542222900Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESAXC47-50D2026-09-22
00840542222917Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESAXC47-4M2026-09-22
00840542222924Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESMUC47-UC2026-09-22
00840542222931Anti-Hepatocyte specific antigen(HAS)BIOGENEX LABORATORIESMUC47-5UC2026-09-22
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONPA08012026-09-04
00846405004782Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4262026-06-08
00846405004799Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob426-052026-06-08
00846405004805Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob426-012026-06-08
00846405007134Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1622026-06-08
00846405017584Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM162-HL2026-06-08
00846405022427Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM162-S2026-06-08
00847627041692Hepatocyte Specific Antigen (HSA)BIOCARE MEDICAL LLCNPAI166T402025-08-18
00810170553226IHCSlmp, LLC(BTO) Sample Hepatocyte Specific Antigen (OCH1E5) 2025-03-14
00810170551543IHCSlmp, LLC(BTO) Hepatocyte Specific Antigen (OCH1E5) Antibod2025-03-06
00810170551550IHCSlmp, LLC(BTO) Manual Hepatocyte Specific Antigen (OCH1E5) 2025-03-06
B502BSB56240Tinto Hepatocyte Specific Antigen/ Hep-Par1, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB56270Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB56280Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB56290Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329224Mouse Monoclonal Anti-Human Hepatocyte(MX119) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1034 10mL2024-02-01
06931988330916Mouse Monoclonal Anti-Human Hepatocyte(MX119) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1034 90mL2024-02-01
06931988321723Mouse Monoclonal Anti-Human Hepatocyte(MX119) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1034 1.0mL2024-01-26
06931988321716Mouse Monoclonal Anti-Human Hepatocyte(MX119) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-1034 0.2mL2024-01-24
00810113068954Rabbit Monoclonal Anti-Human HNF4 Alpha P1, EP366Epitomics Inc.AC-0334BULK2023-06-21
00810113068978Rabbit Monoclonal Anti-Human HNF4 Alpha P1, EP366Epitomics Inc.AC-0334B2023-06-21
00810113068992Rabbit Monoclonal Anti-Human HNF4 Alpha P1, EP366Epitomics Inc.AC-03342023-06-21
00810113065861Rabbit Monoclonal Anti-Human CPS1 (Hep Par-1) Antibody, EP265Epitomics Inc.AC-0229BULK2023-06-15
00810113065885Rabbit Monoclonal Anti-Human CPS1 (Hep Par-1) Antibody, EP265Epitomics Inc.AC-0229B2023-06-15
00810113065878Rabbit Monoclonal Anti-Human CPS1 (Hep Par-1) Antibody, EP265Epitomics Inc.AC-0229A2023-06-13
00810113065892Rabbit Monoclonal Anti-Human CPS1 (Hep Par-1) Antibody, EP265Epitomics Inc.AC-02292023-06-13
00810113068961Rabbit Monoclonal Anti-Human HNF4 Alpha P1, EP366Epitomics Inc.AC-0334A2023-06-13
00810119670830ANTI-HSABIOGENEX LABORATORIESAM550-5M2023-05-11
00841683107200Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-902022-11-14
00841683131564Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-942022-11-14
00841683131595Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-972022-11-14
00841683131618Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary AntibodCELL MARQUE CORPORATION264R-142022-11-14
00841683131625Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary AntibodCELL MARQUE CORPORATION264R-152022-11-14
00841683131632Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary AntibodCELL MARQUE CORPORATION264R-162022-11-14
00841683131649Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary AntibodCELL MARQUE CORPORATION264R-172022-11-14
00841683131656Hepatocyte Specific Antigen (Hep-Par1) (EP265) Rabbit Monoclonal Primary AntibodCELL MARQUE CORPORATION264R-182022-11-14
00841683100720Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-43502020-11-24
05700572006657Mono Mo A-Hu Hepatocyte Cl OCH1E5AGILENT TECHNOLOGIES SINGAPORE PTE LTDM71582020-09-17
05700572029427FLEX Mono Mo A-Hu Hepatocyte Cl OCH1E5 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6242020-09-17
05700572029724FLEX Mono Mo A-Hu Hepatocyte Cl OCH1E5 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6242020-09-17
05700572034223FLEX Mono Mo A-Hu Hepatocyte Cl OCH1E5 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6242020-09-17
B502BSB56250Tinto Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB56260Tinto Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683131571Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-952020-08-21
00841683131588Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-962020-08-21
00841683131601Hepatocyte Specific Antigen (Hep Par-1) (OCH1E5) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION264M-982020-08-07
00615233007407Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8374-C0102020-03-31
00615233007520Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8374-M2502020-03-31
L502BSB5627Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB5628Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB5629Hepatocyte Specific Antigen/ Hep-Par1 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16