FDA.reportPublic FDA data

HemaPrep

Primary DI
07350040976753
Brand
HemaPrep
Company
Cellavision AB
Model
XU-10012-01
Device description
Semi-Automated Blood Smearing Device
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GKJSpinner, Slide, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKJSpinner, Slide, AutomatedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040976753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040976753073500409767537350040976753

GMDN Terms#

Term, Definition table
TermDefinition
Blood smearing manual instrument IVDA manual laboratory instrument intended to be used to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. The device operates with technician involvement in most procedural steps.

Regulatory Flags#

DUNS number
508663101
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040977194CellaVision® Remote Review Single EditionCRRS-SI0099CRRS-SI00992026-05-08
07350040975091CellaVision DC-1XU-103012020-10-22
07350040975107CellaVision DC-1 PPAXU-103022020-10-22
07350040970201CellaVision® DM96XU-10020-01XU-10020-012016-09-20
07350040971277CellaVision® DM1200XU-10127-01XU-10127-012016-09-20
07350040972021Automated Digital Morphology Analyzer DI-60CC286297CC2862972016-09-20
07350040974322CellaVision® DM9600XU-10288-01XU-10288-012016-09-20
07350040972557CellaVision® Body Fluid Application DM1200CBF-120099CBF-1200992016-09-20
07350040972564CellaVision® Body Fluid Application DM96CBF-960099CBF-9600992016-09-20
07350040973707CellaVision® Remote Review Software version 5.0.x, Annual licenseCRRS-005001CRRS-0050012016-09-23
07350040973714CellaVision® Remote Review Software version 5.0.x, Non-expiring licenseCRRS-005099CRRS-0050992016-09-23
07350040973745CellaVision® Advanced RBC Application DM1200CAR-120099CAR-1200992018-03-05
07350040973752CellaVision® Advanced RBC Application DM96CAR-960099CAR-9600992018-03-05
07350040973769CellaVision® Advanced RBC Application DM9600CAR-970099CAR-9700992018-03-05
07350040973776CellaVision® Body Fluid Application DM9600CBF-970099CBF-9700992016-09-20
07350040974506CellaVision® Remote Review Software version 6.0.x, Annual licenseCRRS-006001CRRS-0060012016-09-23
07350040974513CellaVision® Remote Review Software version. 6.0.x, Non-expiring licenseCRRS-006099CRRS-0060992016-09-23
07350040974537CellaVision® Remote Review Software, Enterprise Edition, version 6.0.xCRRS-EN6099CRRS-EN60992016-09-23
07350040974544CellaVision® Remote Review Software, Enterprise upgrade from Group Ed.CRRS-ENGR99CRRS-GRGR992019-02-19
07350040974551CellaVision® Remote Review Software, Enterprise upgrade from Team Ed.CRRS-ENTE99CRRS-ENTE992019-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010522301HemaprepJ P Gilbert Company IncGKJ2023-10-13
00380740071899CELL-DYNABBOTT LABORATORIESGKJ2023-08-25
15099590330620LH SlidemakerBeckman Coulter, Inc.GKJ2020-08-31
07350040972304HemaPrepCellavision ABGKJ2018-11-07
15099590192679UniCel DxHBeckman Coulter, Inc.GKJ2016-09-23