FDA.reportPublic FDA data

CD163 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 CD163 cell marker in a clinical specimen.
GUDID devices
56
Last updated
2026-09-14 22:39:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONPA07942026-09-04
00846405000319Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4602026-06-08
00846405000326Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob460-052026-06-08
00846405000333Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob460-012026-06-08
00846405015344Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5792026-06-08
00846405015351Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM579-S2026-06-08
00846405016549Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM579-252026-06-08
00846405018970Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM579-HL2026-06-08
08719327451014CD163 PURE IQ Products B.V.IQP-570P2023-01-26
08719327451021CD163 FITCIQ Products B.V.IQP-570F2023-01-26
08719327451038CD163 R-PEIQ Products B.V.IQP-570R2023-01-26
08719327451045CD163 BiotinIQ Products B.V.IQP-570B2023-01-26
00847627039644CD163BIOCARE MEDICAL LLCNPAI353T40 2025-03-20
B502BSB32720Tinto CD163, RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB32730Tinto CD163, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB32740Tinto CD163, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB32750CD163 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB32760CD163 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB32770CD163 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB63060CD163 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB63070CD163 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB63080CD163 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB63030Tinto CD163, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
06931988328821Mouse Monoclonal Anti-Human CD163(MX081) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0869 10mL2024-01-31
06931988330527Mouse Monoclonal Anti-Human CD163(MX081) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0869 90mL2024-01-31
06931988309868Mouse Monoclonal Anti-Human CD163(MX081) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0869 1.0mL2024-01-26
06931988309851Mouse Monoclonal Anti-Human CD163(MX081) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0869 0.2mL2024-01-23
05055331320704NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDCD163-L-U2023-07-28
05055331334367BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0090-U2023-07-28
00810113068398Rabbit Monoclonal Anti-Human CD163 Antibody, EP324Epitomics Inc.AC-0316B2023-06-21
00810113068411Rabbit Monoclonal Anti-Human CD163 Antibody, EP324Epitomics Inc.AC-0316A2023-06-21
00810113068428Rabbit Monoclonal Anti-Human CD163 Antibody, EP324Epitomics Inc.AC-0316BULK2023-06-21
00810113068404Rabbit Monoclonal Anti-Human CD163 Antibody, EP324Epitomics Inc.AC-03162023-06-13
00810119673893Anti-CD163BIOGENEX LABORATORIESMUA02-UC2023-04-18
00810119672056Anti-CD163BIOGENEX LABORATORIESAMA02-5M2023-04-05
00847627007193CD163BIOCARE MEDICAL LLCCM353AK2022-12-07
00847627007209CD163BIOCARE MEDICAL LLCCM353CK2022-12-07
00847627011589CD163BIOCARE MEDICAL LLCPM353AA2022-12-07
00841683125297CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION163M-162022-11-14
00841683125303CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION163M-172022-11-14
00841683125310CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION163M-182022-11-14
00841683100942CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-44372021-04-15
05055331323712Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD163-L-CE2021-03-19
05055331325600BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA00902021-03-19
00841683125273CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION163M-142020-12-07
00841683125280CD163 (MRQ-26) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION163M-152020-12-07
B502BSB63040Tinto CD163 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB63050Tinto CD163 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
L502BSB3275CD163 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB3276CD163 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB3277CD163 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
L502BSB6306CD163 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB6307CD163 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB6308CD163 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
00615233000538Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8245-C0102020-01-01
00615233000545Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8245-M2502020-01-01