FDA.reportPublic FDA data

Epredia

Primary DI
00673693087926
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Hematoxylin 7211
Catalog number
7211
Device description
Hematoxylin 7211 is a rapid, progressive hematoxylin. The product is a hybrid between classical Harris and Gill formulations: it provides the classic intensity and hues of a Harris hematoxylin and the rapid progressive qualities of a Gill hematoxylin. Differentiation is not required, but if desired Clarifier 1 should be used. Clarifier 1 will eliminate any background staining that may be caused by the use of excess gelatin or other adhesives in the water bath. Clarifier 2 can be used as well; however, a shorter immersion time is required. Hematoxylin 7211 does not have an affinity for acid mucopolysaccharide (mucin) staining, as do some other hematoxylin formulations. It provides consistent, well-delineated nuclear staining results.
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
HYJHematoxylin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693087926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693087926006736930879266736930879260673693087926

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
04015630972135Hematoxylin IIVentana Medical Systems, Inc.HYJ2025-12-15
B502BSB03601000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB036010000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360150Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB03602000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360500Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
08435421273498Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
08435804516624Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
00849832027171Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-20
00849832027041Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-19
10849832023064Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
20849832018081Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018087Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018049Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832020783Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832022817Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00673693089609EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-06
00673693087940EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087964EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693089807EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693089821EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693210126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483162EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483216EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483223EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693483230EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087971EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693087995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693088008EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03