FDA.reportPublic FDA data

Epredia

Primary DI
00673693091671
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Denatured Ethanol High Purity
Catalog number
9200-5
Device description
Denatured Ethyl Alcohol is specifically designed for tissue processing and staining of histological and cytological specimens. The product is a clear, colorless reagent that is quality controlled. Denatured Ethyl Alcohol contains methyl alcohol, a known toxin. Precaution should be taken when handling Denatured Ethyl Alcohol. Protective gloves should be worn and work should be performed in a ventilated area. Denatured Ethyl Alcohol can be used with both open and closed tissue processors. It is also compatible with all manual staining procedures and automatic stainers. Denatured Ethyl Alcohol 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

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693091671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693091671006736930916716736930916710673693091671

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

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
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENTDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFERDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891328849CHORUS SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
00847627043726NeoPath Background Punisher BIOCARE MEDICAL LLCPPM2026-03-11
04049016151302FITC-labelled anti-human IgA with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
00630414312460Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414312507Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
05407010129847Buffer C_SUO-001_Module L : 1000L BagLonza VerviersPPM2026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampLonza VerviersPPM2026-02-05
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)BIOCARE MEDICAL LLCPPM2026-01-29
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
05430003908471SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908693SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908631SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908709SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908730LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908785LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908808LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908846LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908860LaCAR Lacar MDX TechnologiesPPM2026-01-15
08435804522199FISH PT KITVITRO SAPPM2026-01-15
08435804522212DEWAX-2 FISHVITRO SAPPM2026-01-15
08435804522366FISH PT KITVITRO SAPPM2026-01-15
08435804522397DEWAX-2 FISH VITRO SAPPM2026-01-15