FDA.reportPublic FDA data

Epredia

Primary DI
00673693219372
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Xylene Substitute
Catalog number
1900231
Device description
Xylene Substitute Mountant was specially formulated for its compatibility with Epredia™ Xylene Substitute, but it will work very well in all routine mounting of specimens with xylene. Although compatible with Xylene Substitute, this mounting medium is not soluble in it. See the section on “Removing A Coverslip” on Instructions for Use.
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LEBMounting Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEBMounting MediaPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693219372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693219372006736932193726736932193720673693219372

GMDN Terms#

Term, Definition table
TermDefinition
Microscopy mounting medium IVDA substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04049016151982Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
04049016152002Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
20613647028616FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028654FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00860012688937ClaraMount™ Coverslip mounting mediumClarapath, Inc.LEB2024-08-23
00673693073189EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088947EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088954EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088961EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693088978EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693169745EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693170383EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693218627EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219389EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219396EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693219402EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693228701EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235921EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235938EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693235945EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236058EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236065EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693236072EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693237482EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693237499EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693270427EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
00673693275194EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEB2024-07-30
04049016151999Mounting medium (IFA)EUROIMMUN Medizinische Labordiagnostika AGLEB2022-12-08
00847627002464Fluoro Care Anti-Fade MountantBIOCARE MEDICAL LLCLEB2022-09-23
00847627002471Fluoro Care Anti-Fade MountantBIOCARE MEDICAL LLCLEB2022-09-23