FDA.reportPublic FDA data

Epredia

Primary DI
00673693089340
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Congo Red Solution
Catalog number
88005
Device description
The Amyloid Stain kit is a special stain technique to identify amyloid in tissue sections. Amyloid, a fiber-like protein, can be stained with Congo Red solution. Sodium Hydroxide is added to the solution to break down hydrogen bonds between adjacent amyloid fibers allowing more bonding sites for the Congo Red. A light counterstain with Mayer’s hematoxylin allows contrast. Amyloid can be best detected by the use of green birefringence under a polarized lens of a light microscope. Care should be taken to section tissue sections at a thickness of 7-10 microns for optimal staining.
Published
2024-08-23
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
00673693089340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089340006736930893406736930893400673693089340

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

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
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