FDA.reportPublic FDA data

Epredia

Primary DI
00673693169028
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Masson Trichrome Stain Kit
Catalog number
87019
Device description
"""Masson Trichrome Stain Kit and its components are used as a special stain kit to distinguish between collagen and smooth muscle fibers."""
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
00673693169028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693169028006736931690286736931690280673693169028

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
Kit
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
00673693089869EprediaRICHARD-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