FDA.reportPublic FDA data

Epredia

Primary DI
00673693089869
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Gomori’s Trichrome Stain Green Collagen
Catalog number
88031
Device description
Gomori’s Trichrome Stain Kit Green Collagen and its components are used as a special stain kit to distinguish between collagen and muscle fibers. The cytoplasmic stain and the collagen stain are combined into one solution along with phosphotungstic-phosphomolybdic and glacial acetic acids. Muscle cells and cytoplasm favor the red dyes, and this is facilitated by the phosphotungstic acid. Collagen fibers take up the tungstate ion, allowing for the green dye to selectively bind.
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
HYWStain, Trichrome, Mallory'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYWStain, Trichrome, Mallory'SHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693089869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089869006736930898696736930898690673693089869

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
00673693169028EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693169042EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693089845EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00673693169035EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00840733103452Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2021-07-07
00840733102547EcoStainMERIDIAN BIOSCIENCE, INC.HYW2020-12-09
00840733102585Hemo-DeMERIDIAN BIOSCIENCE, INC.HYW2020-12-09
00840733101960Para-Pak TRICHROME STAINMERIDIAN BIOSCIENCE, INC.HYW2020-10-06
00840733102431Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2020-09-21
00840733102660Modified Hemo-DeMERIDIAN BIOSCIENCE, INC.HYW2020-09-21
00845275005011Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsHYW2016-09-16