FDA.reportPublic FDA data

Epredia

Primary DI
00673693069649
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Three-Step Fixative
Catalog number
3303
Device description
The Three-Step Stain Set is comprised of three components: a methanol fixative (Fixative), an aqueous eosin solution (Solution A), and an aqueous methylene blue/azure A solution (Solution B). The staining solutions consist of xanthene and thiazine dyes, exhibiting both anionic and cationic properties, respectively. Cationic cellular components, such as erythrocytes and eosinophilic granules, share an affinity for the anionic dye of Solution A. The negatively charged phosphate groups of DNA and basophilic granules of the cytoplasm have an affinity for the polychromatic cationic dyes of Solution B. The aqueous stain formulations function to dissociate and activate the dye ions, allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solutions is a critical factor
Published
2024-08-23
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
HYFGiemsa Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693069649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693069649006736930696496736930696490673693069649

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
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
00673693067782EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYF2024-09-06
00673693069564EprediaRICHARD-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
20613647023635FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
20613647023642FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
00816085021164Alpha-Tec SystemsAlpha-TEC Systems, Inc.HYF2022-08-10
00816085022079Alpha-Tec SystemsAlpha-TEC Systems, Inc.HYF2022-08-10
00816085022246Alpha-Tec SystemsAlpha-TEC Systems, Inc.HYF2022-08-10
00816085022581Alpha-Tec SystemsAlpha-TEC Systems, Inc.HYF2022-08-10
00816085022642Alpha-Tec SystemsAlpha-TEC Systems, Inc.HYF2022-08-10
00630414473482Hematek® Stain Pak - Wirght-Giemsa StainSiemens Healthcare Diagnostics Inc.HYF2020-09-24
00630414503929ADVIA® Autoslide Wright Giemsa StainSiemens Healthcare Diagnostics Inc.HYF2020-09-24
00630414503950ADVIA® Autoslide Wright-Giemsa StainSiemens Healthcare Diagnostics Inc.HYF2020-09-24
00630414594958ADVIA Autoslide May Grunwald StainSiemens Healthcare Diagnostics Inc.HYF2020-09-24
00630414594965ADVIA Autoslide Giemsa StainSiemens Healthcare Diagnostics Inc.HYF2020-09-24
00630414594972ADVIA Autoslide May-Grunwald Giemsa BufferSiemens Healthcare Diagnostics Inc.HYF2020-09-24