FDA.reportPublic FDA data

Epredia

Primary DI
00673693483209
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Eosin-Y
Catalog number
7111L
Device description
Eosin-Y is an acidified, alcoholic counterstain that provides excellent delineation of cytoplasmic components and stains the cytoplasm of muscle, red blood cells, and connective tissue three distinct color hues of pink to red. Eosin-Y provides excellent contrast between cytoplasmic components and the bluish-purple hues of the nuclear chromatin.
Published
2024-09-04
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
HYBEosin Y

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYBEosin YHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693483209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693483209006736934832096736934832090673693483209

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
10849832015786Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832002642Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832017981Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
00849832015789Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-17
10849832015779Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-16
00849832013099Leica BiosystemsLeica Biosystems Richmond, Inc.HYB2024-12-16
00673693087346EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087360EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087377EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087384EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087391EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087407EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693087445EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228503EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228510EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228589EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228596EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228602EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
00673693228619EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYB2024-09-04
06973471960668BioSci™Shenzhen Dakewe Bio-engineering Co., LtdHYB2023-09-12
07290012140891QwikCheck Vitality KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.HYB2023-06-08
00613647023150FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYB2022-12-07
20613647023154FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYB2022-12-07
00847627014443Rubens Eosin-PhloxineBIOCARE MEDICAL LLCHYB2022-12-07
00847627014436Edgar Degas EosinBIOCARE MEDICAL LLCHYB2022-09-23
04015630974757VENTANA HE 600 EosinVentana Medical Systems, Inc.HYB2021-08-31
07350025610191NidaconNidacon International ABHYB2017-12-15