FDA.reportPublic FDA data

BRCA1 protein 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 BRCA1 protein in a clinical specimen.
GUDID devices
13
Last updated
2026-06-17 06:05:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405003402Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4242026-06-08
00846405003419Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob424-052026-06-08
00846405003426Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob424-012026-06-08
B502BSB33000Tinto BAP1, MMabBIO SB, INC.Predilute, 3 ml2020-06-01
B502BSB33010Tinto BAP1,MMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB33020Tinto BAP1, MMabBIO SB, INC.Predilute, 15 ml2020-06-01
B502BSB33030BAP1 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB33040BAP1 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB33050BAP1 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00810119671561ANTI-BRCA1 PROTEINBIOGENEX LABORATORIESAR345-5R2023-05-11
L502BSB3303BAP1 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB3304BAP1 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB3305BAP1 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16