Epredia

Primary DI
00673693089388
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Alcoholic Hematoxylin Solution
Catalog number
88007
Device description
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
Published
2024-08-27
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

Related Records

Product Codes

CodeName
LEEStains, Dye Solution

Product Code Classifications

CodeDeviceSpecialtyClass
LEEStains, Dye SolutionHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693089388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089388006736930893886736930893880673693089388

GMDN Terms

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

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

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