FDA.report

Epredia

Primary DI
00673693236348
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Kwik-Diff™ Stain Kit
Catalog number
9990700
Device description
"This staining kit simplifies quick differential staining blood smears and fine needle aspirates with its compact size making it specially ideal for FNA carts. With the Rapid-Chrome Kwik- Diff Staining Kit, all of the necessary reagents and accessories are supplied in one convenient, portable tray. Reagents are sequentially aligned so that the user can dip slides progressively from jar to jar. Additionally, die-cut slots in the tray base accommodate jar lids in order to reduce potential cross-contamination of reagents as well as required counter space. This kit can stain approximately 100 slides, although the actual number may vary based upon sample type and thickness."
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

Related Records

Product Codes

CodeName
HYFGiemsa Stain

Product Code Classifications

CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693236348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693236348006736932363486736932363480673693236348

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
true
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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