FDA.reportPublic FDA data

CD68 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 CD68 cell marker in a clinical specimen.
GUDID devices
74
Last updated
2026-06-16 06:05:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405003976Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob1672026-06-05
00846405003983Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob167-052026-06-05
00846405003990Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob167-012026-06-05
00846405004966Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob0942026-06-05
00846405004973Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob094-052026-06-05
00846405004980Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob094-012026-06-05
00846405006915Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM066-252026-06-05
00846405006922Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0662026-06-05
00846405007196Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM0652026-06-05
00846405017447Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM066-HL2026-06-05
00846405018116Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM065-HL2026-06-05
00846405020058Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob094-B2026-06-05
00846405021307Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM065-S2026-06-05
00846405021314Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM066-S2026-06-05
00846405025503Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob094-BLK2026-06-05
07613336228333CD68 (SP251v18) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.101618760012025-07-07
00847627036735CD68 [KP1]BIOCARE MEDICAL LLCNPAI033T402025-03-20
00810170552878IHCSlmp, LLC(BTO) Sample CD68 Macrophage (KP1) Antibody (2ml)2025-03-12
00810170551000IHCSlmp, LLCRTU CD68 Macrophage (KP-1) Antibody (10ml)2025-03-05
B502BSB27120Tinto CD68,MMabBIO SB, INC.Predilute, 3 ml2020-06-01
B502BSB27130Tinto CD68,MMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB27140Tinto CD68,MMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB27150CD68 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB27160CD68 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB27170CD68 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB52910CD68 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB52920CD68 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB52930CD68 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988328999Mouse Monoclonal Anti-Human CD68(MX075) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0863 10mL2024-02-01
06931988331159Mouse Monoclonal Anti-Human CD68(MX075) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0863 90mL2024-02-01
06931988309462Mouse Monoclonal Anti-Human CD68(MX075) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0863 1.0mL2024-01-26
06931988309455Mouse Monoclonal Anti-Human CD68(MX075) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0863 0.2mL2024-01-25
05055331333476NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDCD68-L-U2023-07-28
05055331334770BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0273-U2023-07-28
00810119675194ANTI-CD68BIOGENEX LABORATORIESMU416-UC2023-05-05
00810119675774ANTI-CD68BIOGENEX LABORATORIESMU549-UC2023-05-05
00810119678225ANTI-CD68BIOGENEX LABORATORIESAM416-10M2023-04-24
00810119674302ANTI-CD68BIOGENEX LABORATORIESMU416-5UC2023-04-19
00810119671219ANTI-CD68BIOGENEX LABORATORIESAM549-5M2023-03-31
00810119670335ANTI-CD68BIOGENEX LABORATORIESAM416-5M2023-03-28
00841683125365CD68 (Kp-1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION168M-972022-11-14
00841683125372CD68 (Kp-1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION168M-982022-11-14
00847627014795CD68 [KP1] BSA Free (1.0mg/ml)BIOCARE MEDICAL LLCACC033CF2022-09-23
00847627031556CD68 [KP1] BSA Free (1.0mg/ml)BIOCARE MEDICAL LLCACC033CFW2022-09-23
05055331304360BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA02732021-03-12
05055331322319Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD68-L-CE2021-03-12
04015630971831CONFIRM anti-CD68 [KP-1] Primary AntibodyVentana Medical Systems, Inc.052782520012021-01-29
05700572003373Mono Mo A-Hu CD68/FITC Cl KP1AGILENT TECHNOLOGIES SINGAPORE PTE LTDF71352020-09-17
05700572005667Mono Mo A-Hu CD68 Cl KP1AGILENT TECHNOLOGIES SINGAPORE PTE LTDM08142020-09-17
05700572006022Mono Mo A-Hu CD68 Cl PG-M1AGILENT TECHNOLOGIES SINGAPORE PTE LTDM08762020-09-17
05700572013372Mono Mo A-Hu CD68 Cl PG-M1AGILENT TECHNOLOGIES SINGAPORE PTE LTDM08762020-09-17
05700572018988Mono Mo A-Hu CD68 Cl EBM11AGILENT TECHNOLOGIES SINGAPORE PTE LTDM07182020-09-17
05700572029175FLEX Mono Mo A-Hu CD68 Cl PG-M1 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6132020-09-17
05700572029267FLEX Mono Mo A-Hu CD68 Cl PG-M1 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6132020-09-17
05700572029618FLEX Mono Mo A-Hu CD68 Cl KP1 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6092020-09-17
05700572029915FLEX Mono Mo A-Hu CD68 Cl KP1 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6092020-09-17
05700572033295FLEX Mono Mo A-Hu CD68 Cl KP1 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6092020-09-17
05700572033387FLEX Mono Mo A-Hu CD68 Cl PG-M1 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6132020-09-17
B502BSB52880Tinto CD68 MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB52890Tinto CD68 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB52900Tinto CD68 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683125334CD68 (Kp-1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION168M-942020-08-07
00841683125341CD68 (Kp-1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION168M-952020-08-07
00841683125358CD68 (Kp-1) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION168M-962020-08-07
00615233003188Genemed®SAKURA FINETEK U.S.A., INC.61-01842019-12-28
00615233005915Genemed®SAKURA FINETEK U.S.A., INC.60-0184-72019-12-28
L502BSB2715CD68 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB2716CD68 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB2717CD68 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
L502BSB5291CD68 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB5292CD68 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB5293CD68 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
00615233000910Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8275-C0102020-01-01
00615233000927Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.8275-M2502020-01-01