FDA.reportPublic FDA data

Chromogenic substrate reagent IVD

Definition
A reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.
GUDID devices
80
Last updated
2020-10-08 08:32:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB00720PolyDetector Alk Brown Ready-To-UseBIO SB, INC.15 ml2020-09-30
B502BSB00730PolyDetector Alk Brown Ready-To-UseBIO SB, INC.50 ml2020-09-30
B502BSB00740PolyDetector Alk Brown Ready-To-UseBIO SB, INC.100 ml,2020-09-30
B502BSB00750PolyDetector Alk Brown Ready-To-UseBIO SB, INC.200 ml,2020-09-30
B502BSB00780PolyDetector Alk MagentaBIO SB, INC.50 ml2020-09-30
B502BSB00790PolyDetector Alk MagentaBIO SB, INC.100 ml2020-09-30
B502BSB00800PolyDetector Alk MagentaBIO SB, INC.200 ml, (2000 Tests)2020-09-30
B502BSB00810PolyDetector Alk MagentaBIO SB, INC.1000 ml2020-09-30
B502BSB01400PolyDetector Alk ScarletBIO SB, INC.100 ml2020-09-30
B502BSB01410PolyDetector Alk ScarletBIO SB, INC.200 ml2020-09-30
B502BSB01420PolyDetector Alk ScarletBIO SB, INC.1000 ml2020-09-30
B502BSB00110PolyDetector Liquid AEC HRP RedBIO SB, INC. Ready-To-Use 15 ml2020-08-31
B502BSB00120PolyDetector Liquid AEC HRP RedBIO SB, INC.Ready-To-Use, 50 ml2020-08-31
B502BSB00130PolyDetector Liquid AEC HRP RedBIO SB, INC.Ready-To-Use, 100 ml2020-08-31
B502BSB00140PolyDetector Liquid AEC HRP RedBIO SB, INC.Ready-To-Use, 200 ml2020-08-31
B502BSB00150PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.150 Tests2020-08-31
B502BSB00160PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.500 tests2020-08-31
B502BSB00170PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.1000 tests2020-08-31
B502BSB00180PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.2000 tests2020-08-31
B502BSB0018A0PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.5000 tests2020-08-31
B502BSB0018B0PolyDetector Liquid DAB HRP Brown kitBIO SB, INC.10000 Tests2020-08-31
B502BSB00190PolyDetector DAB HRP Brown BufferBIO SB, INC.1,000 ml2020-08-31
B502BSB0019A0PolyDetector DAB HRP Brown ChromogenBIO SB, INC.100 ml2020-08-31
B502BSB0019B0PolyDetector DAB HRP Brown ChromogenBIO SB, INC.50 ml2020-08-31
B502BSB0019C0PolyDetector DAB HRP Brown ChromogenBIO SB, INC.12 ml2020-08-31
B502BSB0019D0PolyDetector DAB HRP Brown BufferBIO SB, INC.500 ml2020-08-31
B502BSB0019E0PolyDetector DAB HRP Brown BufferBIO SB, INC.200 ml2020-08-31
B502BSB0019F0PolyDetector DAB HRP Brown BufferBIO SB, INC.100 ml2020-08-31
B502BSB0019G0PolyDetector DAB HRP Brown ChromogenBIO SB, INC.6 ml2020-08-31
B502BSB00610PolyDetector Liquid AEC HRP RedBIO SB, INC.Ready-To-use, 1000 ml2020-08-31
B502BSB0061A0PolyDetector Liquid AEC HRP RedBIO SB, INC.Ready-To-use, 500 ml2020-08-31
B502BSB00620PolyDetector Alk Blue Ready-To-UseBIO SB, INC.15 ml2020-08-31
B502BSB00630PolyDetector Alk Blue Ready-To-UseBIO SB, INC.50 ml2020-08-31
B502BSB00640PolyDetector Alk Blue Ready-To-UseBIO SB, INC.100 ml2020-08-31
B502BSB00650PolyDetector Alk Blue Ready-To-UseBIO SB, INC.200 ml2020-08-31
B502BSB00660PolyDetector Alk Blue Ready-To-UseBIO SB, INC.1000 ml2020-08-31
B502BSB00670PolyDetector Alk Red Ready-To-UseBIO SB, INC.15 ml2020-08-31
B502BSB00680PolyDetector Alk Red Ready-To-UseBIO SB, INC.50 ml2020-08-31
B502BSB00690PolyDetector Alk Red Ready-To-UseBIO SB, INC.100 ml2020-08-31
B502BSB00700PolyDetector Alk Red Ready-To-UseBIO SB, INC.200 ml2020-08-31
B502BSB00710PolyDetector Alk Red Ready-To-UseBIO SB, INC.1000 ml2020-08-31
B502BSB00760PolyDetector Alk Brown Ready-To-UseBIO SB, INC.1000 ml2020-08-31
B502BSB00770PolyDetector Alk MagentaBIO SB, INC.15 ml2020-08-31
B502BSB00870PolyDetector HRP Black kitBIO SB, INC.150 Tests2020-08-31
B502BSB00880PolyDetector HRP Black kitBIO SB, INC.500 Tests2020-08-31
B502BSB00890PolyDetector HRP Black kitBIO SB, INC.1000 Tests2020-08-31
B502BSB0090A0PolyDetector HRP Black kitBIO SB, INC.2000 Tests2020-08-31
B502BSB0090B0PolyDetector HRP Black kitBIO SB, INC.5000 Tests2020-08-31
B502BSB0090C0PolyDetector HRP Black kitBIO SB, INC.10000 Tests2020-08-31
B502BSB01280PolyDetector HRP Green kitBIO SB, INC.150 Tests2020-08-31
B502BSB01290PolyDetector HRP Green kitBIO SB, INC.500 Tests2020-08-31
B502BSB01300PolyDetector HRP Green kitBIO SB, INC.1000 Tests2020-08-31
B502BSB01310PolyDetector HRP Green kitBIO SB, INC.2000 Tests2020-08-31
B502BSB01320PolyDetector HRP Green kitBIO SB, INC.5000 Tests2020-08-31
B502BSB01330PolyDetector HRP Green kitBIO SB, INC.10000 Tests2020-08-31
B502BSB01380PolyDetector Alk ScarletBIO SB, INC.15 ml,2020-08-31
B502BSB01390PolyDetector Alk ScarletBIO SB, INC.50 ml2020-08-31
B502BSB01430PolyDetector HRP Blue kitBIO SB, INC.150 Tests2020-08-31
B502BSB01440PolyDetector HRP Blue kitBIO SB, INC.500 Tests2020-08-31
B502BSB01450PolyDetector HRP Blue kitBIO SB, INC.1000 Tests2020-08-31
B502BSB01460PolyDetector HRP Blue kitBIO SB, INC.2000 Tests2020-08-31
B502BSB01470PolyDetector HRP Blue kitBIO SB, INC.5000 Tests2020-08-31
B502BSB01480PolyDetector HRP Blue kitBIO SB, INC.10000 Tests2020-08-31
00819398027137OxiSticks™HARDY DIAGNOSTICSZ1932020-08-06
00819398028592N/AHARDY DIAGNOSTICSZ1202020-08-06
00819398027250N/AHARDY DIAGNOSTICSZ1112020-07-09
00615233002976Genemed®SAKURA FINETEK U.S.A., INC.10-00482019-12-28
00615233006905Genemed®SAKURA FINETEK U.S.A., INC.10-00472019-12-28
05391516746533Trinity BiotechCLARK LABORATORIES, INC.5257002019-12-27
00840937107485Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-125-302016-08-31
00840937107492Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-125-7502016-08-31
00840937107508Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-126-302016-08-31
00840937107515Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-126-602016-08-31
00840937107522Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-126-7502016-08-31
00840937107539Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-127-302016-08-31
00840937107546Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-127-7502016-08-31
00840937107577Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-244-302016-08-31
00840937107584Immunalysis CorporationIMMUNALYSIS CORPORATIONCH-244-7502016-08-31
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.25142016-12-09
00847865001816Bio-RadBio-RAD Laboratories, Inc.261822014-09-04