FDA.reportPublic FDA data

Epredia

Primary DI
00673693228534
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
EA-50 Papanicolaou Stain
Catalog number
6766002
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
Rx
false
OTC
false
Sterile
false
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
00673693228534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228534006736932285346736932285340673693228534

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
00673693235747EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-09-04
00673693088206EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
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
00673693088312EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088329EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088343EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088367EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088374EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088381EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693088404EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228541EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228558EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228565EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
00673693228572EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHZJ2024-08-09
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SO430852042008Rowley Biochemical Scott's WaterTRANSENE COMPANY, INC.HZJ2019-09-13
15420045510159ThinPrepHologic, Inc.HZJ2018-08-15
15420045510166ThinPrepHologic, Inc.HZJ2018-08-15
15420045509689ThinPrepHologic, Inc.HZJ2018-07-25