FDA.reportPublic FDA data

Mast cell protease 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 a mast cell protease (e.g., tryptase, chymase) in a clinical specimen.
GUDID devices
28
Last updated
2026-06-16 06:05:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405001750Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob3472026-06-05
00846405001767Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob347-052026-06-05
00846405001774Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob347-012026-06-05
00846405002351Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob3462026-06-05
00846405002368Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob346-052026-06-05
00846405002375Diagnostic BioSystemsDiagnostic Biosystems, Inc.Mob346-012026-06-05
00846405006144Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1602026-06-05
00846405006342Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM1592026-06-05
00846405017836Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM159-HL2026-06-05
00846405017843Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM160-HL2026-06-05
00846405020522Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM160-S2026-06-05
00846405022052Diagnostic BioSystemsDiagnostic Biosystems, Inc.PDM159-S2026-06-05
00847627041210Mast Cell Tryptase [AA1]BIOCARE MEDICAL LLCNPAI3277T402025-07-11
00810170553288IHCSlmp, LLC(BTO) Sample Mast Cell Chymase (CC1) Antibody (2mL2025-03-14
00810170553295IHCSlmp, LLC(BTO) Sample Mast Cell Tryptase (AA1) Antibody (2m2025-03-14
00810170551673IHCSlmp, LLC(BTO) Mast Cell Chymase (CC1) Antibody (10ml)2025-03-06
00810170551680IHCSlmp, LLC(BTO) Manual Mast Cell Chymase (CC1) Antibody (6ml2025-03-06
00810170551697IHCSlmp, LLC(BTO) Mast Cell Tryptase (AA1) Antibody (10ml)2025-03-06
00810170551703IHCSlmp, LLC(BTO) Manual Mast Cell Tryptase (AA1) Antibody (6m2025-03-06
B502BSB23770Tinto Tryptase ,RMabBIO SB, INC.Predilute, 3 ml 2020-06-01
B502BSB23780Tinto Tryptase, RMabBIO SB, INC.Predilute, 7 ml 2020-06-01
B502BSB23790Tinto Tryptase, RMabBIO SB, INC.Predilute, 15 ml 2020-06-01
B502BSB23800Tryptase RMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB23810Tryptase RMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB23820Tryptase RMabBIO SB, INC.Concentrate, 1 ml 2020-03-16
B502BSB59900Tryptase MMabBIO SB, INC.Concentrate, 0.1 ml 2020-03-16
B502BSB59910Tryptase MMabBIO SB, INC.Concentrate, 0.5 ml 2020-03-16
B502BSB59920Tryptase MMabBIO SB, INC.Concentrate, 1 ml 2020-03-16