FDA.reportPublic FDA data

CD43 cell marker 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 CD43 cell marker in a clinical specimen.
GUDID devices
44
Last updated
2026-06-16 06:05:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405003075Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0392026-06-05
00846405003082Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob039-052026-06-05
00846405003099Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob039-012026-06-05
00846405006656Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM060-252026-06-05
00846405006663Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0602026-06-05
00846405018109Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM060-HL2026-06-05
00846405019717Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM060-10MM2026-06-05
00846405021215Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM060-S2026-06-05
05055331335517BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0938-U2022-12-16
10190302011235Human CD43 FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD43012018-05-16
10190302011242Human CD43 R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD43042018-05-16
10190302011259Human CD43 APC ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD43052018-05-16
00847627042019CD43BIOCARE MEDICAL LLCNPAI005T402025-12-16
00810170552816IHCSlmp, LLC(BTO) Sample CD43, T Cell Antibody (2ml)2025-03-12
00810170550959IHCSlmp, LLC(BTO) RTU CD43, T Cell (DF-T1) Antibody (10ml)2025-03-05
B502BSB52420CD43 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB52430CD43 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB52440CD43 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00810119675651ANTI-CD43BIOGENEX LABORATORIESMU305-UC2023-05-05
00810119672537ANTI-CD43BIOGENEX LABORATORIESAN748-5M2023-04-06
00810119671387ANTI-CD43BIOGENEX LABORATORIESAM305-5M2023-04-03
04015630971220Anti-CD43 (L60) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.052669800012022-12-07
00841683124856CD43 (MT1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION143M-142022-11-14
00841683124863CD43 (MT1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION143M-152022-11-14
00841683124870CD43 (MT1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION143M-162022-11-14
00841683124887CD43 (MT1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION143M-172022-11-14
05055331303745BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA09382021-04-16
05055331306005Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDMT1-L-U2021-04-16
05700572005575Mono Mo A-Hu CD43 Cl DF-T1AGILENT TECHNOLOGIES SINGAPORE PTE LTDM07862020-09-17
05700572030003FLEX Mono Mo A-Hu CD43 Cl DF-T1 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6362020-09-17
05700572030096FLEX Mono Mo A-Hu CD43 Cl DF-T1 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6362020-09-17
05700572031772Mono Mo AHu CD43/FITC Cl DF-T1AGILENT TECHNOLOGIES SINGAPORE PTE LTDF71022020-09-17
05700572034254FLEX Mono Mo A-Hu CD43 Cl DF-T1 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6362020-09-17
B502BSB52390Tinto CD43 MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB52400Tinto CD43 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB52410Tinto CD43 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683124894CD43 (MT1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION143M-182020-08-21
L502BSB5242CD43 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB5243CD43 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB5244CD43 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00615233000972Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8279-M2502020-01-01
00615233000989Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8279-C0102020-01-01
00382906551580N/ABecton, Dickinson And Company6551582018-11-28
00382906554307N/ABecton, Dickinson And Company6554302018-11-28