Epredia

Primary DI
00673693088909
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Flex 95
Catalog number
8201
Device description
Signature Series Flex is a patented dehydrating reagent specifically designed for processing and staining of histological and cytological tissue specimens. Flex is a clear, colorless blend of isopropyl and methyl alcohol. It is a non-controlled substance and does not require record keeping. Flex is available in concentrations of 80%, 95% and 100%. It is readily miscible with water to form any desired grade of alcohol. Flex is miscible with all clearing reagents. Studies have indicated that Flex does not over-dehydrate small tissue specimens as rapidly as ethyl and isopropyl alcohol, when used in accordance with the processing guidelines developed for Flex. The absence of over-dehydration during tissue processing allows for consistent results with both large and small tissue specimens. Flex can be used in tissue processing, staining and as a dye or stain solvent in place of ethyl alcohol. Flex can be used in all special stains that require dehydration in ethyl alcohol and in immunohistochemical reactions that are compatible with alcoholic dehydrants. Flex has been proven to produce brilliant hematoxylin and eosin stains, with crisp nuclear detail when used within designated guidelines. Flex is compatible with both open and closed tissue processors. Flex is a flammable product and must be stored in a flammable fire cabinet.
Published
2024-07-28
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
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693088909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693088909006736930889096736930889090673693088909

GMDN Terms

TermDefinition
Reagent grade alcohol solution IVDA reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.

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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