FDA.reportPublic FDA data

Epredia

Primary DI
00673693228299
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Rapid-Fixx™
Catalog number
6764212
Device description
Rapid-Fixx™ is a uniquely formulated, formaldehyde-base fixative recommended for frozen sections.
Published
2024-09-04
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

Product Codes#

Code, Name table
CodeName
LDZFixative, Alcohol Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228299006736932282996736932282990673693228299

GMDN Terms#

Term, Definition table
TermDefinition
Frozen tissue fixative IVDA solution intended to be used as a fixative in the processing of frozen tissue sections derived from biological tissues or clinical specimens, for subsequent in vitro diagnostic analysis.

Sterilization Methods#

Method table
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

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
00673693181723EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-11-19
00673693085465EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693556729EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693755146EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00860011780571Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00860011780588Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00380740129590AlinityAbbott GmbHLDZ2023-11-16
M84941012Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021409Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085020181Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021300Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021423Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085021485Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022161Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022277Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022307Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022451Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022475Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022482Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10
00816085022505Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-10