FDA.report

Epredia

Primary DI
00673693089609
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Hematoxylin 1
Catalog number
88018
Device description
"Periodic Acid-Schiff Stain Kit is a staining kit used to detect carbohydrates, glycogen, basement membranes, and fungus in tissue sections for the diagnosis of general pathology specimens. Periodic acid oxidizes these various tissue moieties to aldehydes, to which Schiff Reagent bonds in its colorless form. Rinsing with water removes the sulfurous acid and restores the Schiff Reagent to its rose-colored form."
Published
2024-09-06
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
00673693089609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089609006736930896096736930896090673693089609

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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