Epredia

Primary DI
00673693089746
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Sodium Thiosulfate Solution (5%)
Catalog number
88025
Device description
"""Modified Grocott’s Methenamine Silver Stain Kit (Chromic Acid) is intended for use as an aid to identify fungal organisms and basement membranes in tissue sections for the diagnosis of general pathology specimens. Fungal cell walls are rich in polysaccharides known as glucans. Treatment with either periodic acid or chromic acid oxidizes these polysaccharides to form aldehyde groups; however, chromic acid is the stronger oxidizer. Chromic acid will achieve a greater degree of oxidation, rendering some chemical groups non-reactive with silver so that they are not demonstrated within the final stain. This greater level of oxidation also results in reduced background staining of basement membranes and collagen fibers, as well as more effective demonstration of Pneumocystis jiroveci (formerly classified as Pneumocystis carinii) and Histoplasma capsulatum (the causative organism of Histoplasmosis). After oxidation, Sodium Metabisulfite Solution removes residual Chromic Acid Solution from the tissue. The aldehyde groups react with the silver ions present in the Working Methenamine Silver Solution and reduce them to form visible metallic silver. Gold Chloride Solution tones the sections and intensifies the reduced silver by forming a silver-gold complex. Sodium Thiosulfate Solution removes any unreduced silver from the tissue sections, followed by Fast Green Stain Solution which produces a light green background to further enhance contrast."""
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
LEDStains, Chemical Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEDStains, Chemical SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693089746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089746006736930897466736930897460673693089746

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
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
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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

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Primary DI, Brand, Company table
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