FDA.reportPublic FDA data

Epredia

Primary DI
00673693235730
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Rapid-Chrome H&E Frozen Section Staining Kit
Catalog number
9990001
Device description
The Rapid-Chrome™ H&E Frozen Section Staining Kit simplifies the routine staining of frozen tissue sections from a cryostat. With the Rapid-Chrome™ Staining Kit, all of the reagents needed for H&E-stained frozen sections are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar.
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
LEEStains, Dye Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEEStains, Dye SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693235730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693235730006736932357306736932357300673693235730

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
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
00849832013471Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-22
00849832020523Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832021247Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832021308Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832027034Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832013464Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2024-12-19
00673693089661EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693089906EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202282EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202305EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693089487EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-05
00673693089388EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089401EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089425EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089463EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693169004EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693202145EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-23
00673693202121EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-12
00673693089302EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-09
00673693181846EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181891EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181907EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181914EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181921EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181938EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181945EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222181EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222198EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222204EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06