FDA.reportPublic FDA data

Epredia

Primary DI
00673693090483
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Phosphate Buffer pH 6.6
Catalog number
89032
Device description
"""Phosphate Buffer pH 6.6/7.2 is used as a buffer in staining peripheral blood and bone marrow smears to aid in the diagnosis of general pathology specimens. Phosphate Buffer pH 6.6 and Phosphate Buffer pH 7.2 are white crystalline powders that, when reconstituted, yield 1 liter of clear liquid. These buffers are designed to be used with the Epredia Giemsa, Wright, Wright-Giemsa, May-Grünwald, and Jenner hematology stains"""
Published
2024-09-05
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
LEFStains, Dye Powder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEFStains, Dye PowderHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693090483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693090483006736930904836736930904830673693090483

GMDN Terms#

Term, Definition table
TermDefinition
Phosphate buffer/Sorenson buffer solution IVDA phosphate buffer or Sorenson buffer solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

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
00673693089708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEF2024-09-06
00673693090490EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEF2024-09-05
M52550360o-Dianisidine (Powder) (1 x 2 g)HELENA LABORATORIES CORPORATIONLEF2017-03-17