FDA.reportPublic FDA data

Programmed death-1 (PD-1) 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 programmed death-1 (PD-1), also known as CD279, in a clinical specimen.
GUDID devices
60
Last updated
2026-06-18 06:05:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405002740Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4752026-06-09
00846405002757Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob475-052026-06-09
00846405002764Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob475-012026-06-09
00846405006519Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM190-252026-06-09
00846405006526Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1902026-06-09
00846405014408Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob573-012026-06-09
00846405014415Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob573-052026-06-09
00846405017911Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM573-HL2026-06-09
00846405022618Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM190-S2026-06-09
00846405014392Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob5732026-06-04
00846405015245Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5732026-06-04
00846405015252Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM573-S2026-06-04
00846405016600Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM573-252026-06-04
05055331334640BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA0216-U2022-12-16
00847627041166PD-L1BIOCARE MEDICAL LLCNPAI3171T402025-07-11
B502BSB31480Tinto PD-1/CD279, RMabBIO SB, INC.Predilute, 3 ml2020-06-01
B502BSB31510PD-1/CD279 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB31520PD-1/CD279 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB31530PD-1/CD279 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
B502BSB62130Tinto PD-1/CD279, MMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB62140Tinto PD-1/CD279, MMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB62150PD-1/CD279 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB62160PD-1/CD279 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB62170PD-1/CD279 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329552Mouse Monoclonal Anti-Human PD-1(MX033) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0734 10mL2024-01-31
06931988330183Mouse Monoclonal Anti-Human PD-1(MX033) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0734 90mL2024-01-31
06931988304641Mouse Monoclonal Anti-Human PD-1(MX033) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0734 1.0mL2024-01-25
06931988304634Mouse Monoclonal Anti-Human PD-1(MX033) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0734 0.2mL2024-01-23
00810119679918ANTI-PD-L1BIOGENEX LABORATORIESAN921-5MSG2023-05-04
00810119672612ANTI-PD-1BIOGENEX LABORATORIESAM922-5M2023-04-06
05055331331229BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA02162022-12-07
00382906651310HorizonBecton, Dickinson And Company6651312022-11-16
00841683144090PD-1 (EP239) Rabbit Monoclonal Primary Antibody CELL MARQUE CORPORATION315R-18 2022-11-14
00841683144106PD-1 (EP239) Rabbit Monoclonal Primary Antibody CELL MARQUE CORPORATION315R-17 2022-11-14
00382906651242N/ABecton, Dickinson And Company6651242022-10-12
00847627003218PD-1BIOCARE MEDICAL LLCACI3137AK2022-09-23
00847627003225PD-1BIOCARE MEDICAL LLCACI3137CK2022-09-23
00847627004321PD-1BIOCARE MEDICAL LLCAPI3137AA2022-09-23
00847627004482PD-1 (RM)BIOCARE MEDICAL LLCAPI3162AA2022-09-23
00847627013972PD-1 [CAL20]BIOCARE MEDICAL LLCACI3224A2022-09-23
00847627013989PD-1 [CAL20]BIOCARE MEDICAL LLCACI3224B2022-09-23
00847627014016PD-1 [CAL20]BIOCARE MEDICAL LLCAPI3224AA2022-09-23
00841683101543PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-48952021-04-15
00841683135333PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION315M-972020-12-14
00841683135340PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION315M-982020-12-14
B502BSB31490Tinto PD-1/CD279 RMabBIO SB, INC.Predilute, 7 ml2020-08-31
B502BSB31500Tinto PD-1/CD279 RMabBIO SB, INC.Predilute, 15 ml2020-08-31
B502BSB62120Tinto PD-1/CD279 MMabBIO SB, INC.Predilute ,3 ml 2020-08-31
00841683119456PD-1 (EP239) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION315R-152020-08-28
00841683119548PD-1 (EP239) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION315R-142020-08-28
00841683144113PD-1 (EP239) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION315R-162020-08-28
00841683135302PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION315M-942020-08-21
00841683135319PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION315M-952020-08-21
00841683135326PD-1 (NAT105) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION315M-962020-08-21
L502BSB3151PD-1/CD279 RMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
L502BSB3152PD-1/CD279 RMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB3153PD-1/CD279 RMabBIO SB, INC.Concentrate, 1 ml2020-03-16
L502BSB6215PD-1/CD279 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB6216PD-1/CD279 MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
L502BSB6217PD-1/CD279 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16