FDA.reportPublic FDA data

Epredia

Primary DI
00673693088480
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Saccomanno Fluid
Catalog number
76161
Device description
Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.
Published
2024-07-19
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
LEAPreservative, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693088480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693088480006736930884806736930884800673693088480

GMDN Terms#

Term, Definition table
TermDefinition
Saccamanno solution IVDA solution typically containing 50% ethanol and 2% polyethylene glycol (carbowax) diluted in water, intended to be used as a fixative particularly for liquid cytologic specimens such as sputum, urine, bronchial washings, and pleural and peritoneal fluids. Saccomanno solution causes lysis of red blood cells and renders uncoagulated proteins and mucus soluble for centrifugation and filtration.

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
10849832027819Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2026-05-22
09551020410030PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410047PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410108PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410115PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410146PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410221PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410238PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410245PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410252PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410283PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410436PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410443PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410450PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410467PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410474PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410481PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410498PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
00613647028629FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
20613647028623FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
10849832002946Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00849832002949Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00810160180357SUPMEDICSupmedics Inc.LEA2024-11-04
00673693483032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-10-22
00673693105279EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693105286EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230858EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230865EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344692EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04