Epredia

Primary DI
00673693235747
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Rapid Chrome™ Papanicolaou Staining Kit
Catalog number
9990020
Device description
The Rapid-Chrome™ Papanicolaou Staining Kit is specially designed to facilitate the staining of cytology specimens. It is ideally suited to quickly stain fine needle aspirates, and it also prevents cross-contamination of routine staining dishes from high-risk cases. With the Rapid-ChromeTM Papanicolaou Staining Kit, all of the reagents needed for Pap-stained cytology specimens 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. All reagents are sequentially aligned to allow the slide to be moved from one jar to the next.
Published
2024-09-04
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
HZJStain, Papanicolau

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HZJStain, PapanicolauHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693235747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693235747006736932357476736932357470673693235747

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
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00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
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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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