FDA.reportPublic FDA data

Epredia

Primary DI
00673693067782
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Modified Wright-Giemsa Stain Pack
Catalog number
3005
Device description
The Modified Wright and Modified Wright-Giemsa Stain Packs are reagent systems designed for optimal performance on Hematek® slide stainers and used for differential staining of blood films. These systems consist of a modified polychrome methylene blue- eosin stain and are based on the original stain proposed by Dmitri Romanowsky (Romanowsky, D. [1891] St. Petersb. Med. Wschr., 16, 297-307
Published
2024-09-06
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
HYFGiemsa Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693067782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693067782006736930677826736930677820673693067782

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
00630414619248Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414619255Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323596Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323602Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
04015630971404Giemsa Staining KitVentana Medical Systems, Inc.HYF2025-12-15
00673693068192EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090353EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090377EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090414EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090421EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090438EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090445EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693090476EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693236409EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-05
00673693069564EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069649EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069700EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693069717EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236348EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236355EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236362EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236379EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236386EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00673693236393EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-08-23
00860011780526Chemical Service Labs, LLCProtean Resources, LLC.HYF2024-03-18
00860011780533Chemical Service Labs, LLCProtean Resources, LLC.HYF2024-03-18
00848838027086REMELREMEL, INC.HYF2022-12-23
00613647023631FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
00613647023648FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
20613647023635FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07