FDA.reportPublic FDA data

Congo Red Stain Core Kit

Primary DI
07613336239063
Brand
Congo Red Stain Core Kit
Company
Ventana Medical Systems, Inc.
Model
10585021001
Catalog number
10585021001
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
07613336239063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336239063076133362390637613336239063

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
184042521
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20
07613336240434ASSY RGT DSPNR CARD BMK PREP KIT 31610637609001106376090012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693089135EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICH2024-08-23
00673693089340EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICH2024-08-23
SO920852042008Rowley Biochemical Congo Red, 10% AqueousTRANSENE COMPANY, INC.ICH2022-12-16
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