FDA.reportPublic FDA data

Epithelial 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 epithelial antigen in a clinical specimen.
GUDID devices
28
Last updated
2026-06-16 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405002085Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4062026-06-05
00846405002092Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob406-052026-06-05
00846405002108Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob406-012026-06-05
00846405005505Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0622026-06-05
00846405005512Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob062-052026-06-05
00846405005529Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob062-012026-06-05
00846405006267Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1312026-06-05
00846405007332Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0772026-06-05
00846405017539Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM131-HL2026-06-05
00846405018154Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM077-HL2026-06-05
00846405020324Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM077-S2026-06-05
00846405021727Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM131-S2026-06-05
00846405024353Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM131-252026-06-05
00847627038753Ber-EP4BIOCARE MEDICAL LLCNPAI107T402025-03-20
00847627038760Ber-EP4BIOCARE MEDICAL LLCNPAI107T802025-03-20
00810170553141IHCSlmp, LLC(BTO) Sample EA Epithelial Antigen (Ber-EP4) Antib2025-03-14
00810170551444IHCSlmp, LLCRTU EA Epithelial Antigen (Ber-EP4) Antibody (10ml2025-03-05
00847627011008Ber-EP4BIOCARE MEDICAL LLCPM107AA2022-12-07
00847627011015Ber-EP4BIOCARE MEDICAL LLCPM107H2022-12-07
00847627024886Ber-EP4BIOCARE MEDICAL LLCAVI107G2022-12-07
00847627008619Ber-EP4BIOCARE MEDICAL LLCIP107G102022-09-23
00847627025371Ber-EP4BIOCARE MEDICAL LLCOPAI107T602022-09-23
05700572005629Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4AGILENT TECHNOLOGIES SINGAPORE PTE LTDM08042020-09-17
05700572013341Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4AGILENT TECHNOLOGIES SINGAPORE PTE LTDM08042020-09-17
05700572030010FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6372020-09-17
05700572030089FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6372020-09-17
05700572034261FLEX Mono Mo A-Hu Epithelial Antigen Cl Ber-EP4 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6372020-09-17
05700572515838Mono Mo A-Hu Epithelial Antigen/FITC Cl Ber-EP4AGILENT TECHNOLOGIES SINGAPORE PTE LTDF08602020-09-17