FDA.report

Epredia

Primary DI
00673693556729
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Pen-Fix™
Catalog number
6115
Device description
Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in certain circumstances, other fixatives may be desired according to tissue type or subsequent pretreatment or staining technique. Pen-Fix is an alcoholic formalin variation with the addition of a proprietary buffer salt.
Published
2024-07-24
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
LDZFixative, Alcohol Containing

Product Code Classifications

CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693556729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693556729006736935567296736935567290673693556729

GMDN Terms

TermDefinition
Neutral buffered formalin IVDA neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.

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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