FDA.reportPublic FDA data

Epredia

Primary DI
00673693228367
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Glyo-Fixx™ Concentrate
Catalog number
6764265
Device description
Glyo-Fixx is formulated for use as a histological fixative, to replace formalin and zinc formalin for routine specimens as well as those intended for immunohistochemical or special staining procedures. It is also effective as a secondary fixative after unbuffered or buffered formalin or zinc formalin.
Published
2024-07-25
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
IFLPolyethylene Glycol Preservative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFLPolyethylene Glycol PreservativePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228367006736932283676736932283670673693228367

GMDN Terms#

Term, Definition table
TermDefinition
Formalin substitute solution IVDA formalin substitute solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.

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
00673693228343EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFL2024-07-25
00673693228350EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFL2024-07-25
00673693236614EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFL2024-07-25
00673693236621EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFL2024-07-25
00673693236645EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIFL2024-07-25