Epredia

Primary DI
00673693088343
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
EA-50 Papanicolaou Stain
Catalog number
75525
Device description
EA-36, -50, -65 and Modified EA are ready-to-use cytoplasmic counterstains used for gynecological and non-gynecological cytology specimens. These products contain common dyes and reagent solvents used in traditional EA formulations. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results. Cellular results are traditional as well, with basal or intermediate cells staining a blue-green hue and surface cells staining a pink-red hue. This multicolored effect is due to dye uptake by various cells and their affinities for the specific dyes.EA 50 is used in conjunction with OG-6 for the staining of gynecological specimens. It will provide a very traditional staining result with common staining hues and intensities. EA-50 can also be used for non-gynecological specimens however, although EA-65 is recommended.
Published
2024-08-09
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
HZJStain, Papanicolau

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HZJStain, PapanicolauHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693088343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693088343006736930883436736930883430673693088343

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

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Primary DI, Brand, Model table
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00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
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00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
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00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
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00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
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00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00673693088213EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088244EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088275EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088282EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088305EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
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