FDA.reportPublic FDA data

Rowley Biochemical Congo Red, 10% Aqueous

Primary DI
SO920852042008
Brand
Rowley Biochemical Congo Red, 10% Aqueous
Company
TRANSENE COMPANY, INC.
Model
1
Device description
Congo Red, 10% Aqueous
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ICHCongo Red

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICHCongo RedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
SO920852042008PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Regulatory Flags#

DUNS number
044815983
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution1SO-4712019-09-16
SO959852042008Rowley Biochemical Congo Red, 0.1% Aqueous1SO-9592019-09-16
E3021A852042008Rowley Biochemical Crystal Violet Working Solution1E-302-1A2019-09-16
E3031852042008Rowley Biochemical Sirius Red F3BA Solution1E-303-12019-09-16
E3101852042008Rowley Biochemical Carmine Stock1E-310-12019-09-16
E5852042008Rowley Biochemical Gelatin1E-52019-09-16
F3646852042008Rowley Biochemical Biebrich Scarlet Solution, 1%1F-364-42019-09-16
F3833852042008Rowley Biochemical Gomori's Chromium Hematoxylin1F-383-32019-09-16
R18852042008Rowley Biochemical Biebrich Scarlet, Certified1R-182019-09-16
R34852042008Rowley Biochemical Congo Red, Certified1R-342019-09-16
R36852042008Rowley Biochemical Crystal Violet, Certified1R-362019-09-16
R3852042008Alizarin Red, Certified1R-32019-09-16
R84852042008Rowley Biochemical Nuclear Fast Red1R-842019-09-16
SO1020852042008Rowley Biochemical Crystal Violet, 0.1% Solution1SO-10202019-09-16
SO1076852042008Rowley Biochemical Puchtler's Modification of Congo Red1SO-10762019-09-16
SO1077852042008Rowley Biochemical Sirius Red Solution1SO-10772019-09-16
SO1107852042008Rowley Biochemical Crystal Violet, 2% Aqueous1SO-11072019-09-16
SO1127852042008Rowley Biochemical Crystal Violet, 2.5% in 10% Alcohol1SO-11272019-09-16
SO1256852042008Rowley Biochemical Working Congo Red1SO-12562019-09-16
SO130852042008Rowley Biochemical Nuclear Fast Red Solution1SO-1302019-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336239063Congo Red Stain Core KitVentana Medical Systems, Inc.ICH2026-04-10
00673693089135EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICH2024-08-23
00673693089340EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICH2024-08-23
04015630971701Congo Red Staining KitVentana Medical Systems, Inc.ICH2021-08-27
SO959852042008Rowley Biochemical Congo Red, 0.1% AqueousTRANSENE COMPANY, INC.ICH2019-09-16
R34852042008Rowley Biochemical Congo Red, CertifiedTRANSENE COMPANY, INC.ICH2019-09-16
SO1076852042008Rowley Biochemical Puchtler's Modification of Congo RedTRANSENE COMPANY, INC.ICH2019-09-16
SO1256852042008Rowley Biochemical Working Congo RedTRANSENE COMPANY, INC.ICH2019-09-16
SO275852042008Rowley Biochemical Alcoholic Congo RedTRANSENE COMPANY, INC.ICH2019-09-16
SO312852042008Rowley Biochemical Congo Red 0.5% AqueousTRANSENE COMPANY, INC.ICH2019-09-16
SO496852042008Rowley Biochemical Congo Red 1% AqueousTRANSENE COMPANY, INC.ICH2019-09-16
SO825852042008Rowley Biochemical Congo Red 0.2% in IsopropanolTRANSENE COMPANY, INC.ICH2019-09-16