FDA.reportPublic FDA data

CellaVision® DM9600

Primary DI
07350040974322
Brand
CellaVision® DM9600
Company
Cellavision AB
Model
XU-10288-01
Catalog number
XU-10288-01
Device description
Automated cell locating device. DM9600 automatically locates and presents images of blood cells on peripherall blood smears.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell
JOYDevice, Automated Cell-Locating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2
JOYDevice, Automated Cell-LocatingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092868000CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127CellaVision AB2009-11-20JOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040974322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040974322073500409743227350040974322

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46464601600service@cellavision.se

Regulatory Flags#

DUNS number
508663101
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040977194CellaVision® Remote Review Single EditionCRRS-SI0099CRRS-SI00992026-05-08
07350040976753HemaPrepXU-10012-012023-01-06
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
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
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)Beckman Coulter, Inc.GKZ2026-05-19
07350040977194CellaVision® Remote Review Single EditionCellavision ABJOY2026-05-08
00860008385888WBC Test StripAthelas, Inc.GKZ2026-04-28
00860008385871Athelas HomeAthelas, Inc.GKZ2026-04-27
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
00850063751216CitoCBC CartridgeCYTOCHIP INCGKZ2025-07-01
06944904002422BC-3200 Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.GKZ2025-01-17
04987562508440XQ-520 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2025-01-14
07290118610892X100HT SystemSCOPIO LABS LTDJOY2024-12-01
03610230009444Yumizen H2500HORIBA ABX SASGKZ2024-11-29
03610230009451Yumizen H2500HORIBA ABX SASGKZ2024-11-29
15099590762889Stem-Kit ReagentsBeckman Coulter, Inc.GKZ2024-10-25
15099590762896StemTrol Control CellsBeckman Coulter, Inc.GKZ2024-10-25
07290016991086HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2024-09-02
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.JOY2024-07-02
04987562503131XQ-320 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2024-05-24
00380740138851AlinityABBOTT LABORATORIESGKZ2023-11-16
00382906643438BD Trucount™Becton, Dickinson And CompanyGKZ2023-08-07
07290018417034X100 Digital ScannerSCOPIO LABS LTDJOY2022-12-30
07290018417072X100 Processing Unit (Complete Unit)SCOPIO LABS LTDJOY2022-12-30
07290018417096X100HT Digital Scanner SCOPIO LABS LTDJOY2022-12-30
07290018417126X100HT Processing Unit SCOPIO LABS LTDJOY2022-12-30
07290018417133X100 with Full Field Peripheral Blood Smear ApplicationSCOPIO LABS LTDJOY2022-12-30
07290018417140X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationSCOPIO LABS LTDJOY2022-12-30
00382906654212FACSDivaBecton, Dickinson And CompanyGKZ2022-10-12
20860008385868Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29