FDA.reportPublic FDA data

Epredia

Primary DI
00673693228282
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
TBD-2 Decalcifier
Catalog number
6764004
Device description
Decalcifying Solutions are for in vitro diagnostic used for the removal of calcium in pathological specimens.
Published
2024-07-26
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
KDXSolution, Decalcifier, Acid Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDXSolution, Decalcifier, Acid ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228282006736932282826736932282820673693228282

GMDN Terms#

Term, Definition table
TermDefinition
Decalcifying solution IVDA solution intended to be used as a decalcifying agent in the processing of clinical specimens and biological tissues for subsequent in vitro diagnostic analysis. It is typically in the form of an inorganic acid [e.g., hydrochloric acid (HCl)], organic acid [e.g., formic acid (CH2O2)] or a chelating agent [e.g., ethylenediaminetetraacetic acid (EDTA)].

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
00613647028346FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDX2025-06-30
20613647028340FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDX2025-06-30
00673693078917EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693089050EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693089067EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26
00673693228275EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKDX2024-07-26