FDA.reportPublic FDA data

ClaraMount™ Coverslip mounting medium

Primary DI
00860012688937
Brand
ClaraMount™ Coverslip mounting medium
Company
Clarapath, Inc.
Model
900-00023
Device description
For use as a permanent, resin based mounting medium in histological preparations on slides produced by SectionStar™
Published
2024-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10860012688934PackageGS14In Commercial Distribution
00860012688937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001268893410860012688934
00860012688937008600126889378600126889370860012688937

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
079469240
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012688968Clarapath™ SectionStar™810-000022025-02-04
00860012688944Clarapath™ SectionStar™810-000012024-10-22
00198168976302SectionStar810-000012024-08-16
00860012688906ClaraTape™ Transfer Tape900-000202024-08-23
10860012688903ClaraTape™ Transfer Tape900-000202024-08-23
00860012688913ClaraCut™ Blades900-000222024-08-23
00860012688920ClaraBond™ Slide Coater Adhesive900-000212024-08-23

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
00613647028612FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00613647028650FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028616FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028654FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
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
00673693219372EprediaRICHARD-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 (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2022-12-08