FDA.reportPublic FDA data

Chromogenic/colorimetric substrate reagent IVD

Definition
A substance or reactant that produces colour in response to a biochemical reaction and intended to be used in combination with other IVDs to test a clinical specimen, typically using an enzyme immunoassay or immunoblot method. Substrate examples include NBT, BCIP, TMB, 4CN, DAB.
GUDID devices
94
Last updated
2026-07-17 22:01:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.C0042026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.C004-NI2026-07-09
00846405012770Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0552026-06-08
00846405012787Diagnostic BioSystemsDiagnostic Biosystems, Inc.K050-1102026-06-08
00846405012794Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0502026-06-08
00846405016747Diagnostic BioSystemsDiagnostic Biosystems, Inc.K047B-5 L2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.K047C-1 L2026-06-08
00846405023332Diagnostic BioSystemsDiagnostic Biosystems, Inc.K050-S2026-06-08
00846405023585Diagnostic BioSystemsDiagnostic Biosystems, Inc.K055-S2026-06-08
00846405012800Diagnostic BioSystemsDiagnostic Biosystems, Inc.K062-1102026-06-05
00846405012817Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0622026-06-05
00846405012824Diagnostic BioSystemsDiagnostic Biosystems, Inc.K058-1102026-06-05
00846405012831Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0582026-06-05
00846405012848Diagnostic BioSystemsDiagnostic Biosystems, Inc.K063-1102026-06-05
00846405012855Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0632026-06-05
00846405012862Diagnostic BioSystemsDiagnostic Biosystems, Inc.K059-1102026-06-05
00846405012879Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0592026-06-05
00846405012886Diagnostic BioSystemsDiagnostic Biosystems, Inc.K074-1102026-06-05
00846405012893Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0742026-06-05
00846405012909Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-1102026-06-05
00846405012916Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-S2026-06-05
00846405012923Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-AUTO-1102026-06-05
00846405012930Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-AUTO2026-06-05
00846405012947Diagnostic BioSystemsDiagnostic Biosystems, Inc.K057-AutoPlus-1102026-06-05
00846405012954Diagnostic BioSystemsDiagnostic Biosystems, Inc.K057-AutoPlus2026-06-05
00846405012961Diagnostic BioSystemsDiagnostic Biosystems, Inc.K075-1102026-06-05
00846405012978Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0752026-06-05
00846405012985Diagnostic BioSystemsDiagnostic Biosystems, Inc.K060-1102026-06-05
00846405012992Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0602026-06-05
00846405013005Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0472026-06-06
00846405014101Diagnostic BioSystemsDiagnostic Biosystems, Inc.K081-AUTO2026-06-05
00846405014118Diagnostic BioSystemsDiagnostic Biosystems, Inc.K081-AUTO-1102026-06-05
00846405014125Diagnostic BioSystemsDiagnostic Biosystems, Inc.K081-AUTO-1L2026-06-05
00846405016754Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0512026-06-05
00846405016761Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0522026-06-05
00846405016785Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-1L-AUTO2026-06-05
00846405017119Diagnostic BioSystemsDiagnostic Biosystems, Inc.K051-1102026-06-05
00846405017126Diagnostic BioSystemsDiagnostic Biosystems, Inc.K052-1102026-06-05
00846405022212Diagnostic BioSystemsDiagnostic Biosystems, Inc.K074-S2026-06-05
00846405022229Diagnostic BioSystemsDiagnostic Biosystems, Inc.K060-S2026-06-05
00846405023554Diagnostic BioSystemsDiagnostic Biosystems, Inc.K047-S2026-06-06
00846405023561Diagnostic BioSystemsDiagnostic Biosystems, Inc.K0492026-06-05
00846405023578Diagnostic BioSystemsDiagnostic Biosystems, Inc.K049-AUTO-S2026-06-05
00846405023592Diagnostic BioSystemsDiagnostic Biosystems, Inc.K057-AutoPlus-S2026-06-05
00846405023608Diagnostic BioSystemsDiagnostic Biosystems, Inc.K058-S2026-06-05
00846405023615Diagnostic BioSystemsDiagnostic Biosystems, Inc.K059-S2026-06-05
00846405023622Diagnostic BioSystemsDiagnostic Biosystems, Inc.K063-S2026-06-05
00846405023639Diagnostic BioSystemsDiagnostic Biosystems, Inc.K075-S2026-06-05
00846405023646Diagnostic BioSystemsDiagnostic Biosystems, Inc.K062-S2026-06-05
00846405023653Diagnostic BioSystemsDiagnostic Biosystems, Inc.K081-AUTO-S2026-06-05
00819398028561N/AHARDY DIAGNOSTICSZ1112020-07-09
00819398028646OxiSticks™HARDY DIAGNOSTICSZ1932020-08-06
04049016151838ELISA chromogen/substrate solutionEUROIMMUN Medizinische Labordiagnostika AGZE 1200-10122025-07-02
00810170553646IHCSlmp, LLCUltra High Def Red-AP Chromogen (110ml)2025-03-31
B502BSB03611000PolyDetector HRP BlackBIO SB, INC.BSB-0361-1002025-03-18
B502BSB036110000PolyDetector HRP BlackBIO SB, INC.BSB-0361-10002025-03-18
B502BSB0361150PolyDetector HRP BlackBIO SB, INC.BSB-0361-152025-03-18
B502BSB03612000PolyDetector HRP BlackBIO SB, INC.BSB-0361-2002025-03-18
B502BSB0361500PolyDetector HRP BlackBIO SB, INC.BSB-0361-502025-03-18
B502BSB03615000PolyDetector HRP BlackBIO SB, INC.BSB-0361-5002025-03-18
B502BSB03621000PolyDetector HRP MulberryBIO SB, INC.BSB-0362-1002025-03-18
B502BSB036210000PolyDetector HRP MulberryBIO SB, INC.BSB-0362-10002025-03-18
B502BSB0362150PolyDetector HRP MulberryBIO SB, INC.BSB-0362-152025-03-18
B502BSB03622000PolyDetector HRP MulberryBIO SB, INC.BSB-0362-2002025-03-18
B502BSB0362500PolyDetector HRP MulberryBIO SB, INC.BSB-0362-502025-03-18
B502BSB03625000PolyDetector HRP MulberryBIO SB, INC.BSB-0362-5002025-03-18
B502BSB03631000PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-1002025-03-18
B502BSB036310000PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-10002025-03-18
B502BSB0363150PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-152025-03-18
B502BSB03632000PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-2002025-03-18
B502BSB0363500PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-502025-03-18
B502BSB03635000PolyDetector HRP Blue PlusBIO SB, INC.BSB-0363-5002025-03-18
B502BSB03641000PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-1002025-03-18
B502BSB036410000PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-10002025-03-18
B502BSB0364150PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-152025-03-18
B502BSB03642000PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-2002025-03-18
B502BSB0364500PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-502025-03-18
B502BSB03645000PolyDetector HRP FuchsiaBIO SB, INC.BSB-0364-5002025-03-18
B502BSB03651000PolyDetector HRP YellowBIO SB, INC.BSB-0365-1002025-03-18
B502BSB036510000PolyDetector HRP YellowBIO SB, INC.BSB-0365-10002025-03-18