FDA.reportPublic FDA data

Epredia

Primary DI
00673693089265
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Carbol Fuchsin Solution
Catalog number
88001
Device description
"""The Acid Fast Bacillus Stain Kit (87016) and components are for use as a kit in special stain techniques to detect acid fast bacteria. A waxy, lipid-rich cell wall surrounds the acid fast bacterium. This cell wall absorbs carbol fuchsin but is resistant to decoloration with acid alcohol. Bacteria that do not have a lipid-rich cell wall easily decolorize leaving the acid fast bacillus. Loeffler Methylene Blue Stain Solution provides a light blue counterstain to provide contrast for surrounding tissue elements from the brick red acid fast bacillus."""
Published
2024-08-07
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
ICLCarbol Fuchsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICLCarbol FuchsinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693089265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089265006736930892656736930892650673693089265

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

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
00848838065767REMELREMEL, INC.ICL2022-12-23
00848838065958REMELREMEL, INC.ICL2022-12-23
00816085022086Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-10
00816085023458Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023595Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020822Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020853Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023441Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023588Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
04015630971732AFB III Staining KitVentana Medical Systems, Inc.ICL2021-02-08
07613336157510BenchMark Special Stains AFB Staining KitVentana Medical Systems, Inc.ICL2021-02-08
SO359852042008Rowley Biochemical Kinyoun's Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO490852042008Rowley Biochemical Carbol FuchsinTRANSENE COMPANY, INC.ICL2019-09-16
30382902125113BD BBL™ TB Carbolfuchsin ZNBECTON, DICKINSON AND COMPANYICL2018-05-25
30382902125182BD BBL™ TB Carbolfuchsin KFBECTON, DICKINSON AND COMPANYICL2018-05-25