FDA.reportPublic FDA data

Epredia

Primary DI
00673693235846
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Formal-Fixx™ Concentrate
Catalog number
9990244
Device description
Formal-Fixx is a variation of neutral buffered formalin with a differing buffering system. This fixative is designed especially for use with the Cytoblock processing gel. The phosphate-free buffering system prevents the formation of free formic acid, and its associated artifacts, formalin pigment. The osmolality of these fixatives allows them to be used not only for light microscopy but for electron microscopic studies as well. Zinc Formal-Fixx Concentrate is the same formulation as Formal-Fixx Concentrate but includes the mineral zinc to enhance the nuclear detail of the specimen.
Published
2024-07-25
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
LDYFixative, Formalin-Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDYFixative, Formalin-ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693235846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693235846006736932358466736932358460673693235846

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
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
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338003746Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003760Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003777Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00846338003784Endiscope and accessoriesELLIQUENCE, LLCLDY2026-05-07
00673693167505EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-10-22
00673693080033EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693228312EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693228329EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693228336EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693236577EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693236591EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693236607EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-25
00673693084222EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693084260EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693084338EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693084406EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693084499EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693084543EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693088428EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693177788EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693228305EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693236560EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693576123EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693737906EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-24
00673693079891EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDY2024-07-23
00845275004939Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004946Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004953Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004960Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16
00845275004984Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDY2016-09-16