FDA.reportPublic FDA data

CD19 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 CD19 cell marker in a clinical specimen.
GUDID devices
109
Last updated
2026-10-04 01:48:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00382906718167HorizonBecton, Dickinson And Company6718162026-09-24
00382906718259HorizonBecton, Dickinson And Company6718252026-09-24
00382906718266HorizonBecton, Dickinson And Company6718262026-09-24
00847627042811CD19 (RM) [RM332]BIOCARE MEDICAL LLCNPAI3270T402025-10-31
10190302005524Human CD19 Pacific Blue™  ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19282016-08-01
10190302010641Human CD19 FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19012018-05-06
10190302010658Human CD19 FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD190142018-05-06
10190302010665Human CD19 APC ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19052018-05-06
10190302010672Human CD19 PE-Cy®7 ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19122018-05-06
10190302010689Human CD19 PE-Texas Red® ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19172018-05-06
10190302010696Human CD19 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19182018-05-06
10190302010702Human CD19 Alexa Fluor® 488 ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19202018-05-06
10190302010719Human CD19 Alexa Fluor® 647 ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19212018-05-06
10190302010726Human CD19 PE-Alexa Fluor® 610 Conj.LIFE TECHNOLOGIES CORPORATIONMHCD19222018-05-06
10190302010733Human CD19 APC-Alexa Fluor® 750 Conj.LIFE TECHNOLOGIES CORPORATIONMHCD19272018-05-06
10190302010740Human CD19 Alexa Fluor® 700 Conj.LIFE TECHNOLOGIES CORPORATIONMHCD19292018-05-06
10190302010757Human CD19 PerCP ConjugateLIFE TECHNOLOGIES CORPORATIONMHCD19312018-05-06
B502BSB64670CD19 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB64680CD19 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
00847627042835CD19BIOCARE MEDICAL LLCNPAI310T402026-01-13
B502BSB3840010CD19 (RM332)BIO SB, INC.BSB-3840-012025-03-18
B502BSB3840050CD19 (RM332)BIO SB, INC.BSB-3840-052025-03-18
B502BSB384010CD19 (RM332)BIO SB, INC.BSB-3840-12025-03-18
B502BSB3840150Tinto CD19 (RM332)BIO SB, INC.BSB-3840-152025-03-18
B502BSB384030Tinto CD19 (RM332)BIO SB, INC.BSB-3840-32025-03-18
B502BSB384070Tinto CD19 (RM332)BIO SB, INC.BSB-3840-72025-03-18
B502BSB62290CD19 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB62300CD19 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB62310CD19 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB64650Tinto CD19, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB64690CD19 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
06931988328838Mouse Monoclonal Anti-Human CD19(MX016) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0705 10mL2024-01-31
06931988330138Mouse Monoclonal Anti-Human CD19(MX016) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0705 90mL2024-01-31
06931988303620Mouse Monoclonal Anti-Human CD19(MX016) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0705 1.0mL2024-01-25
06931988303613Mouse Monoclonal Anti-Human CD19(MX016) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0705 0.2mL2024-01-23
05055331333339NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDCD19-163-L-U2023-07-28
05055331335470BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0843-U2023-07-28
00810113063669Rabbit Monoclonal Anti-Human CD19 Antibody, EP169Epitomics Inc.AC-0139B2023-06-09
00810113063676Rabbit Monoclonal Anti-Human CD19 Antibody, EP169Epitomics Inc.AC-01392023-06-09
00810113063683Rabbit Monoclonal Anti-Human CD19 Antibody, EP169Epitomics Inc.AC-0139BULK2023-06-09
00810113063690Rabbit Monoclonal Anti-Human CD19 Antibody, EP169Epitomics Inc.AC-0139A2023-06-09
00810113063706Rabbit Monoclonal Anti-Human CD19 Antibody, EP169Epitomics Inc.AC-0139CMBULK2023-06-09
00810119675132CONC ANTI HUMAN CD19BIOGENEX LABORATORIESNU729-UC2023-05-05
00810119671059ANTI-CD19BIOGENEX LABORATORIESAN729-5M2023-03-31
00847627007070CD19BIOCARE MEDICAL LLCCM310A2022-12-07
00847627011503CD19BIOCARE MEDICAL LLCPM310AA2022-12-07
00841683123842CD19 (MRQ-36) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION119M-142022-11-14
00841683123859CD19 (MRQ-36) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION119M-152022-11-14
00841683123866CD19 (MRQ-36) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION119M-162022-11-14
00841683123873CD19 (MRQ-36) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION119M-172022-11-14
00841683123880CD19 (MRQ-36) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION119M-182022-11-14
00841683123927CD19 (EP169) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION119R-172022-11-14
00847627028280CD19 (RM) [RM332]BIOCARE MEDICAL LLCACI3270A2022-09-23
00847627028297CD19 (RM) [RM332]BIOCARE MEDICAL LLCACI3270C2022-09-23
00847627028303CD19 (RM) [RM332]BIOCARE MEDICAL LLCAPI3270AA2022-09-23
00847627028310CD19 (RM) [RM332]BIOCARE MEDICAL LLCAVI3270G2022-09-23
00847627028327CD19 (RM) [RM332]BIOCARE MEDICAL LLCOPAI3270T602022-09-23
00847627028334CD19 (RM) [RM332]BIOCARE MEDICAL LLCALI3270G72022-09-23
08436548983406CD19-PE-Cyanine7 CYTOGNOS SLCYT-19C4-A2022-09-23
00382906639899HorizonBecton, Dickinson And Company6639892020-11-11
00382906645326HorizonBecton, Dickinson And Company6645322021-07-23
05055331303806BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA08432021-04-09
05055331314475Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD19-163-L-CE2021-04-09
05055331323743Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDCD19-163-L-CE-H2021-04-09
00841683123897CD19 (EP169) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION119R-142020-12-14
00841683123903CD19 (EP169) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION119R-152020-12-14
00841683123910CD19 (EP169) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION119R-162020-12-14
05700572028567Mono Mo A-Hu CD19 Cl LE-CD19AGILENT TECHNOLOGIES SINGAPORE PTE LTDM72962020-09-17
05700572030867FLEX Mono Mo A-Hu CD19 Cl LE-CD19 RTU (Link)AGILENT TECHNOLOGIES SINGAPORE PTE LTDIR6562020-09-17
05700572030959FLEX Mono Mo A-Hu CD19 Cl LE-CD19 RTUAGILENT TECHNOLOGIES SINGAPORE PTE LTDIS6562020-09-17
05700572033967Mono Mo a Hu CD19/PB, Cl HD37AGILENT TECHNOLOGIES SINGAPORE PTE LTDPB9852020-09-17
05700572515388Mono Mo A-Hu CD19/FITC Cl HD37AGILENT TECHNOLOGIES SINGAPORE PTE LTDF07682020-09-17
05700572515524Mono Mo a Hu CD19/APC Cl HD37AGILENT TECHNOLOGIES SINGAPORE PTE LTDC72242020-09-17
B502BSB62260Tinto CD19 MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB62270Tinto CD19 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB62280Tinto CD19 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
B502BSB64640Tinto CD19 RMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB64660Tinto CD19 RMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683123934CD19 (EP169) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION119R-182020-08-07
05700572034339FLEX Mono Mo A-Hu CD19, Cl LE-CD19, RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA6562020-04-03