FDA.reportPublic FDA data

Multiple melanoma 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 multiple markers associated with melanoma [e.g., tyrosinase, Melan-A/MART-1 peptide and/or glycoprotein 100 (gp100)] in a clinical specimen.
GUDID devices
6
Last updated
2025-03-07 15:57:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB69050Tinto Melanoma KBA.62, MMabBIO SB, INC.Predilute, 3 ml2020-06-01
B502BSB69060Tinto Melanoma KBA.62, MMabBIO SB, INC.Predilute, 7 ml2020-06-01
B502BSB69070Tinto Melanoma KBA.62, MMabBIO SB, INC.Predilute, 15 ml2020-06-01
B502BSB69080Melanoma KBA.62 MMabBIO SB, INC.Concentrate, 0.1 ml2020-03-16
B502BSB69090Melanoma KBA.62 MMabBIO SB, INC.Concentrate, 0.5 ml2020-03-16
B502BSB69100Melanoma KBA.62 MMabBIO SB, INC.Concentrate, 1 ml2020-03-16