FDA.reportPublic FDA data

Epredia

Primary DI
00673693089623
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Biebrich Scarlet- Acid Fuchsin Solution
Catalog number
88019
Device description
Biebrich Scarlet-Acid Fuchsin is utilized to stain the acid substances such as the cytoplasm, muscle and collagen. Phosphotungstic-Phosphomolybdic (PTA-PMA) solution is then used to remove the Biebrich Scarlet from the collagen fibers. The cytoplasm will retain the stain due to its permeability. The Aniline Blue is then utilized to restain the decolorized collagen fibers. A 1% Acetic Acid solution may further be used to differentiate the stained tissue section
Published
2024-09-05
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
ICNBiebrich Scarlet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICNBiebrich ScarletHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693089623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089623006736930896236736930896230673693089623

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
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
F3646852042008Rowley Biochemical Biebrich Scarlet Solution, 1%TRANSENE COMPANY, INC.ICN2019-09-16
R18852042008Rowley Biochemical Biebrich Scarlet, CertifiedTRANSENE COMPANY, INC.ICN2019-09-16
SO304852042008Rowley Biochemical Biebrich Scarlet 1% in 1% Acetic AcidTRANSENE COMPANY, INC.ICN2019-09-16
SO305852042008Rowley Biochemical Biebrich Scarlet, 1% AqueousTRANSENE COMPANY, INC.ICN2019-09-16
SO615852042008Rowley Biochemical Biebrich Scarlet Acid FuchsinTRANSENE COMPANY, INC.ICN2019-09-16