FDA.reportPublic FDA data

Epredia

Primary DI
00673693228718
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Nu-Clear™ I
Catalog number
6769008
Device description
Nu-Clear™ is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens.
Published
2024-08-30
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
LEDStains, Chemical Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEDStains, Chemical SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693228718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693228718006736932287186736932287180673693228718

GMDN Terms#

Term, Definition table
TermDefinition
Acid-alcohol solution IVDAn acid-alcohol solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

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
00630414290010Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00630414312484Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00613647028643FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
20613647028647FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
00673693089746EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089920EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089944EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089968EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693201247EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693201995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202015EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202237EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202244EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202268EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693202312EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-06
00673693089647EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693090063EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693090209EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-05
00673693171175EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-09-04
00673693088084EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088091EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088114EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088121EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088138EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088145EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088152EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693088176EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693228671EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30
00673693228688EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLED2024-08-30