FDA.reportPublic FDA data

P57 protein 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 p57 protein, also known as Kip2 or cyclin-dependent kinase inhibitor 1C (CDK1C), in a clinical specimen.
GUDID devices
28
Last updated
2026-06-18 06:05:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405001309Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob2912026-06-09
00846405001316Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob291-052026-06-09
00846405001323Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob291-012026-06-09
00846405014880Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM2052026-06-09
00846405014897Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM205-S2026-06-09
00846405016457Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM205-252026-06-09
00846405018888Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM205-HL2026-06-09
B502BSB61940p57 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB61950p57 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB61960p57 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
05055331321107NovocastraLEICA BIOSYSTEMS NEWCASTLE LTDP57-L-U2023-07-28
00810113065137Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183Epitomics Inc.AC-0205BULK2023-06-13
00810113065144Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183Epitomics Inc.AC-0205B2023-06-13
00810113065151Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183Epitomics Inc.AC-0205A2023-06-13
00810113065168Rabbit Monoclonal Anti-Human p57/Kip2 Antibody, EP183Epitomics Inc.AC-02052023-06-13
05055331328229Novocastra™LEICA BIOSYSTEMS NEWCASTLE LTDP57-L-CE2021-04-23
00841683101321p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION760-46172021-04-15
00841683142836p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION457M-972020-09-15
00841683142843p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION457M-982020-09-15
B502BSB61910Tinto p57 MMabBIO SB, INC.Predilute, 3 ml 2020-08-31
B502BSB61920Tinto p57 MMabBIO SB, INC.Predilute, 7 ml 2020-08-31
B502BSB61930Tinto p57 MMabBIO SB, INC.Predilute, 15 ml 2020-08-31
00841683142805p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION457M-942020-08-28
00841683142812p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION457M-952020-08-28
00841683142829p57/Kip2 (Kp10) Mouse Monoclonal AntibodyCELL MARQUE CORPORATION457M-962020-08-28
L502BSB6194p57 MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
L502BSB6195p57 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
L502BSB6196p57 MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16