FDA.reportPublic FDA data

Epredia

Primary DI
00673693483216
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Hematoxylin 7211
Catalog number
7211L
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
Rx
false
OTC
false
Sterile
false
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
00673693483216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693483216006736934832166736934832160673693483216

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
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
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
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
00673693087926EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
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
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
00673693088015EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693088022EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693228435EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693228442EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03