FDA.report

Epredia

Primary DI
00673693088015
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Gill 1 Hematoxylin (Series R)
Catalog number
72604
Device description
Gill Hematoxylin 1, 2, and 3 are rapid, progressive hematoxylins that are widely known and respected in the histology and cytology fields. They offer convenience and choice of stain intensity. Gill hematoxylins are ready to use and will provide familiar, consistent, well-delineated results. Stain filtering may be needed to remove sheen caused by oxidation or cells shed off of slides in the cytology staining process. Gill 1 is the least intense stain and is most commonly used in cytology and in special stains. Gill 2 is a moderately intense stain and is most commonly used in histology, with some limited use in cytology. Gill 3 is an intense stain and is exclusively used in histology as well as staining of plastic sections.
Published
2024-09-03
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
HYJHematoxylin

Product Code Classifications

CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693088015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693088015006736930880156736930880150673693088015

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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