FDA.reportPublic FDA data

Epredia

Primary DI
00673693228527
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
EA-50 Papanicolaou Stain
Catalog number
6766001
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
KZJDevice, Gas Generating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZJDevice, Gas GeneratingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228527006736932285276736932285270673693228527

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
00382902604679BD BBL ™ GasPak™ 100 Vented LidBECTON, DICKINSON AND COMPANYKZJ2024-08-29
05032384029648ANAEROBIC CATALYSTOXOID LIMITEDKZJ2022-12-12
05032384446148ANAEROGEN COMPACTOXOID LIMITEDKZJ2022-12-12
05032384003761YERSINIA SELECTIVE AGAR BASEOXOID LIMITEDKZJ2022-12-08
05032384028665ANAEROGEN 2.5L 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384028672ANAEROGEN 3.5L 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384028870CAMPYGEN (2.5 LITRES)OXOID LIMITEDKZJ2022-12-08
05032384028887CAMPYGEN (3.5 LITRES)OXOID LIMITEDKZJ2022-12-08
05032384029921ANAEROGEN COMPACT 10 PACKOXOID LIMITEDKZJ2022-12-08
05032384034611CAMPYGEN COMPACT (20 PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384034932CO2GEN (10 SACHETS PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384069132ANAEROGEN COMPACT 20 PACKOXOID LIMITEDKZJ2022-12-08
05032384123261CO2GEN COMPACT (20 PER PACK)OXOID LIMITEDKZJ2022-12-08
05032384161935ANAEROGEN W-ZIP COMPACTOXOID LIMITEDKZJ2022-12-08
05032384028405SINGLE DISC EJECTORSOXOID LIMITEDKZJ2022-12-07
05032384060122DESICCATED CARTRIDGE CONTAINEROXOID LIMITEDKZJ2022-12-07
00816068020900Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)Advanced Instruments, LLCKZJ2020-09-21
00816068020917Advanced Instruments Ergonomic Culture Jar, SmallAdvanced Instruments, LLCKZJ2020-09-21
00816068020924Advanced Instruments Ergonomic Culture Jar, LargeAdvanced Instruments, LLCKZJ2020-09-21
00816068020948Advanced Instruments Standard Anoxomat Jar, MediumAdvanced Instruments, LLCKZJ2020-09-21
00816068020955Advanced Instruments Standard Anoxomat Jar, LargeAdvanced Instruments, LLCKZJ2020-09-21
00816068020962Advanced Instruments Palladox Disposable SatchetAdvanced Instruments, LLCKZJ2020-09-21
30382902600016BD GasPak™ EZ Anaerobe Container System Sachets with IndicatorBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606780BD GasPak™ EZ Anaerobe Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606797BD GasPak™ EZ CO2 Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606803BD GasPak™ EZ Campy Container System SachetsBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606834BD GasPak™ EZ Anaerobe Gas Generating Pouch System with IndicatorBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606841BD GasPak™ EZ CO2 Gas Generating Pouch SystemBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902606858BD GasPak™ EZ Campy Gas Generating Pouch SystemBECTON, DICKINSON AND COMPANYKZJ2018-05-25
30382902612057BD CO2 Gas GeneratorsBECTON, DICKINSON AND COMPANYKZJ2018-05-25