FDA.report

Epredia

Primary DI
00673693089302
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Fast Green Stain Solution
Catalog number
88003
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
2024-08-09
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
LEEStains, Dye Solution

Product Code Classifications

CodeDeviceSpecialtyClass
LEEStains, Dye SolutionHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693089302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089302006736930893026736930893020673693089302

GMDN Terms

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

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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