FDA.reportPublic FDA data

Napsin A 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 napsin A in a clinical specimen.
GUDID devices
97
Last updated
2026-09-14 22:39:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841683151463Napsin A MRQ-60 Mab.CELL MARQUE CORPORATIONPA08052026-09-04
00846405003884Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob4632026-06-09
00846405003891Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob463-052026-06-09
00846405003907Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob463-012026-06-09
00846405006908Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1542026-06-09
00846405018291Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM154-HL2026-06-09
00846405022175Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM154-S2026-06-09
00847627033505Napsin ABIOCARE MEDICAL LLCALI388G72023-01-10
00847627041678Napsin ABIOCARE MEDICAL LLCNPAI434T40 2025-09-05
00847627039309Napsin ABIOCARE MEDICAL LLCNPAI388T402025-03-20
00847627039316Napsin ABIOCARE MEDICAL LLCNPAI388T802025-03-20
B502BSB3789010Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-012025-03-18
B502BSB3789050Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-052025-03-18
B502BSB378910Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-12025-03-18
B502BSB3789150Tinto Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-152025-03-18
B502BSB378930Tinto Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-32025-03-18
B502BSB378970Tinto Napsin A (RBT-NAPSA)BIO SB, INC.BSB-3789-72025-03-18
00810170552441IHCSlmp, LLC(BTO) Sample PDM154-2MM2025-03-07
00810170550454IHCSlmp, LLC(BTO) Napsin A (KCG1.1) Antibody (10mL)2025-03-03
00810170550461IHCSlmp, LLC(BTO) Manual Napsin A (KCG1.1) Antibody (6ml)2025-03-03
B502BSB33920Tinto Napsin A, MMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB33930Tinto Napsin A, MMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB33940Tinto Napsin A,MMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB33950Napsin A MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB33960Napsin A MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB33970Napsin A MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB69880Tinto Napsin A RMabBIO SB, INC.Predilute, 3 ml 2020-05-15
B502BSB69890Tinto Napsin A RMabBIO SB, INC.Predilute, 7 ml 2020-05-15
B502BSB69900Tinto Napsin A RMabBIO SB, INC.Predilute, 15 ml 2020-05-15
B502BSB69910Napsin A RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB69920Napsin A RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB69930Napsin A RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
06931988329460Mouse Monoclonal Anti-Human Napsin A(MX015) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0704 10mL2024-01-31
06931988330121Mouse Monoclonal Anti-Human Napsin A(MX015) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0704 90mL2024-01-31
06931988303583Mouse Monoclonal Anti-Human Napsin A(MX015) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0704 1.0mL2024-01-25
06931988303576Mouse Monoclonal Anti-Human Napsin A(MX015) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0704 0.2mL2024-01-23
05055331334039NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDNAPSINA-L-U2023-07-28
05055331334312BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0064-U2023-07-28
00810113064833Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205Epitomics Inc.AC-0191B2023-06-13
00810113064840Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205Epitomics Inc.AC-01912023-06-13
00810113064857Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205Epitomics Inc.AC-0191A2023-06-13
00810113064864Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205Epitomics Inc.AC-0191CMBULK2023-06-13
00810113064871Rabbit Monoclonal Anti-Human Napsin A Antibody, EP205Epitomics Inc.AC-0191BULK2023-06-13
00847627034977Napsin ABIOCARE MEDICAL LLCPM388H2023-06-09
00810119675439ANTI-NAPSIN ABIOGENEX LABORATORIESMU701-UC2023-05-05
00810119678003ANTI-NAPSIN ABIOGENEX LABORATORIESAM701-10M2023-04-24
00810119670557ANTI-NAPSIN ABIOGENEX LABORATORIESAM701-5M2023-03-29
00841683121480Napsin A (MRQ-60) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION352M-942022-11-14
00841683121497Napsin A (MRQ-60) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION352M-962022-11-14
00841683121503Napsin A (EP205) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION352R-142022-11-14
00841683121510Napsin A (EP205) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION352R-162022-11-14
00841683138143Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION352A-762022-11-14
00841683138150Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION352A-772022-11-14
00841683138167Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION352A-782022-11-14
00841683138174Napsin A (MRQ-60) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION352M-952022-11-14
00841683138198Napsin A (MRQ-60) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION352M-982022-11-14
00841683138204Napsin A (EP205) Rabbit Monoclonal Primary AntibodyCELL MARQUE CORPORATION352R-152022-11-14
00847627002761Napsin A (RM)BIOCARE MEDICAL LLCACI3043A2022-09-23
00847627002778Napsin A (RM)BIOCARE MEDICAL LLCACI3043C2022-09-23
00847627004000Napsin A (RM)BIOCARE MEDICAL LLCAPI3043AA2022-09-23
00847627007339Napsin ABIOCARE MEDICAL LLCCM388AK2022-09-23
00847627007346Napsin ABIOCARE MEDICAL LLCCM388CK2022-09-23
00847627008961Napsin ABIOCARE MEDICAL LLCIPI388G102022-09-23
00847627011817Napsin ABIOCARE MEDICAL LLCPM388AA2022-09-23
00847627012227Napsin ABIOCARE MEDICAL LLCPP434AA2022-09-23
00847627023902Napsin ABIOCARE MEDICAL LLCAVI434G2022-09-23
00847627024671Napsin ABIOCARE MEDICAL LLCAVI388G2022-09-23
00847627025579Napsin ABIOCARE MEDICAL LLCOPAI388T602022-09-23
00850030934734ihcDirect® Napsin A Ab Conjugate 5mLNOVODIAX, INC.H32043-R0052021-08-20
00850030934741ihcDirect® Napsin A Ab Conjugate 15mLNOVODIAX, INC.H32043-R0152021-08-20
00850030934758ihcDirect® Napsin A Ab-Enh 5mLNOVODIAX, INC.K47043-0052021-08-20
00850030934765ihcDirect® Napsin A Ab-Enh 15mLNOVODIAX, INC.K47043-0152021-08-20
00841683101031Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION760-44462021-04-15
05055331305572Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDNAPSINA-L-CE2021-03-19
05055331326485BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA00642021-03-19
00841683138129Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION352A-742020-12-07
00841683138136Napsin A Rabbit Polyclonal AntibodyCELL MARQUE CORPORATION352A-752020-12-07
00841683101505Napsin A (MRQ-60) Mouse Monoclonal Primary AntibodyCELL MARQUE CORPORATION760-48672020-11-24
00850000596702ihcDirect® Napsin A Ab, 5mLNOVODIAX, INC.K32043-0052020-10-26
00850000596719ihcDirect® Napsin A Ab, 15mLNOVODIAX, INC.K32043-0152020-10-26