FDA.reportPublic FDA data

p16 antigen 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 p16 antigen in a clinical specimen.
GUDID devices
65
Last updated
2026-06-18 06:05:17

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405013807Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-NI2026-06-09
00846405013814Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-01-RUO2026-06-09
00846405013821Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-05-RUO2026-06-09
00846405013838Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob5752026-06-09
00846405013845Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-012026-06-09
00846405013852Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-052026-06-09
00846405013869Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-HL2026-06-09
00846405013876Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-10MM2026-06-09
00846405013883Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-10MM-RUO2026-06-09
00846405013890Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob575-RUO2026-06-09
00846405013906Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-100-RUO2026-06-09
00846405013913Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-25-RUO2026-06-09
00846405013920Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-RUO2026-06-09
00846405013937Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-S-RUO2026-06-09
00846405013944Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM5752026-06-09
00846405013951Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-1002026-06-09
00846405013968Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-252026-06-09
00846405013975Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-32026-06-09
00846405013982Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM575-S2026-06-09
04015630970452CINtec HistologyVentana Medical Systems, Inc.50 Tests2017-03-29
04015630970476CINtec HistologyVentana Medical Systems, Inc.066800110012017-03-21
04015630984299CINtec p16 Histology (50) CEVentana Medical Systems, Inc.066952480012025-07-07
00847627038340p16 INK4a [BC42]BIOCARE MEDICAL LLCNPAI3231T402025-06-20
00847627038357p16 INK4a [BC42]BIOCARE MEDICAL LLCNPAI3231T802025-06-20
B502BSB3768010p16 (RM267)BIO SB, INC.BSB-3768-012025-03-18
B502BSB3768050p16 (RM267)BIO SB, INC.BSB-3768-052025-03-18
B502BSB376810p16 (RM267)BIO SB, INC.BSB-3768-12025-03-18
B502BSB3768150Tinto p16 (RM267)BIO SB, INC.BSB-3768-152025-03-18
B502BSB376830Tinto p16 (RM267)BIO SB, INC.BSB-3768-32025-03-18
B502BSB376870Tinto p16 (RM267)BIO SB, INC.BSB-3768-72025-03-18
00810170552717IHCSlmp, LLC(BTO) Sample P16 Antibody (2ml)2025-03-12
00810170550836IHCSlmp, LLCAntibody p16 (JC2) IHC Concentrate 1ml2025-03-03
00810170550843IHCSlmp, LLCRTU P16 (JC2) Antibody (10ml)2025-03-03
06931988329507Mouse Monoclonal Anti-Human P16(MX007) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0673 10mL2024-01-31
06931988330077Mouse Monoclonal Anti-Human P16(MX007) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0673 90mL2024-01-31
06931988302661Mouse Monoclonal Anti-Human P16(MX007) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0673 1.0mL2024-01-25
06931988302654Mouse Monoclonal Anti-Human P16(MX007) AntibodyFuzhou Maixin Biotech Co., Ltd.MAB-0673 0.2mL2024-01-23
05055331334121BONDLEICA BIOSYSTEMS NEWCASTLE LTDPA0016-U2023-07-28
05700573007462FLEX Mono Mo A-Hu p16 Clone JC8 RTU (Dako Omnis)AGILENT TECHNOLOGIES SINGAPORE PTE LTDGA7832023-06-07
00810119677235p16 (INK4a)BIOGENEX LABORATORIESAX540-YCD2023-05-04
00810119677969ANTI-P16(INK4)BIOGENEX LABORATORIESAM540-10M2023-04-24
00810119677808ANTI-P16(INK4)BIOGENEX LABORATORIESAM540-10M2023-04-21
00810119675446ANTI-P16(INK4)BIOGENEX LABORATORIESMU540-UC2023-03-29
00810119670229ANTI-P16(INK4)BIOGENEX LABORATORIESAM540-5M2023-03-28
00847627003737p16 INK4a [BC42]BIOCARE MEDICAL LLCACI3231A2022-12-07
00847627003744p16 INK4a [BC42]BIOCARE MEDICAL LLCACI3231C2022-12-07
00847627004871p16 INK4a [BC42]BIOCARE MEDICAL LLCAPI3231AA2022-12-07
00847627014146p16 INK4a [BC42] BIOCARE MEDICAL LLCAPI3231H2022-12-07
00847627029034p16 INK4a [BC42]BIOCARE MEDICAL LLCAVI3231G252022-12-07
04015630970445CINtec® p16 HistologyVentana Medical Systems, Inc.066952210012022-12-07
05055331329684BOND™LEICA BIOSYSTEMS NEWCASTLE LTDPA00162022-12-07
04015630984398CINtec p16 HistologyVentana Medical Systems, Inc.066952560012021-02-03
B502BSB34760Tinto p16, RMab. BIO SB, INC.Predilute, 3 ml2020-08-31
B502BSB34770Tinto p16, RMabBIO SB, INC.Predilute, 7 ml2020-08-31
B502BSB34780Tinto p16, RMabBIO SB, INC.Predilute, 15 ml 2020-08-31
B502BSB34790p16, RMabBIO SB, INC.Concentrate, 0.1 ml 2020-08-31
B502BSB34800p16, RMabBIO SB, INC.Concentrate, 0.5 ml2020-08-31
B502BSB34810p16, RMabBIO SB, INC.Concentrate, 1 ml2020-08-31
B502BSB58270Tinto p16, MMabBIO SB, INC.Predilute, 3 ml2020-08-31
B502BSB58280Tinto p16, MMab. BIO SB, INC.Predilute, 7 ml2020-08-31
B502BSB58290Tinto p16, MMabBIO SB, INC.Predilute, 15 ml2020-08-31
B502BSB58300p16, MMabBIO SB, INC.Concentrate, 0.1 ml2020-08-31
B502BSB58310p16, MMabBIO SB, INC.Concentrate, 0.5 ml2020-08-31
B502BSB58320p16, MMabBIO SB, INC.Concentrate, 1 ml2020-08-31
00615233007834Genemed®SAKURA FINETEK U.S.A., INC.60-0209-152020-06-23