Cellavision AB

Address:Mobilvagen 12,LUND Skane,SE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Automated Cell-Locating (JOY) (9) Counter, Differential Cell (GKZ) (4) Spinner, Slide, Automated (GKJ) (1)

Premarket Exempt

No Yes

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CellaVision® DM96 - 07350040970201 Catalog Number : XU-10020-01

Device Description : Automated cell locating device. DM96 automatically locates and presents images o Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : GKZ, JOY

Prescription Use : Yes

Device Count : 1

CellaVision® DM1200 - 07350040971277 Catalog Number : XU-10127-01

Device Description : Automated cell locating device. DM1200 automatically locates and presents images Automated cell locating device. DM1200 automatically locates and presents images of blood cells on peripherall blood smears.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : GKZ, JOY

Prescription Use : Yes

Device Count : 1

Automated Digital Morphology Analyzer DI-60 - 07350040972021 Catalog Number : CC286297

Device Description : Automated Digital Morphology Analyzer DI-60 automaticall locates and presents im Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : GKZ, JOY

Prescription Use : Yes

Device Count : 1

HemaPrep - 07350040972304 Catalog Number :

Device Description : Blood smear instrument

Device Class : 1

Duns Number: 508663101

Premarket Exempt : Yes

Product Code : GKJ

Prescription Use : Yes

Device Count : 1

CellaVision® Body Fluid Application DM1200 - 07350040972557 Catalog Number : CBF-120099

Device Description : The body fluid application automatically locates and presents cell images on cyt The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Body Fluid Application DM96 - 07350040972564 Catalog Number : CBF-960099

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : GKZ, JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Remote Review Software version 5.0.x, Annual license - 07350040973707 Catalog Number : CRRS-005001

Device Description : The CellaVision remote review software enable remote users to access data collec The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM instruments with the ability to reclassify cells and sign off slides from another location.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Remote Review Software version 5.0.x, Non-expiring license - 07350040973714 Catalog Number : CRRS-005099

Device Description : The CellaVision remote review software enable remote users to access data collec The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Advanced RBC Application DM1200 - 07350040973745 Catalog Number : CAR-120099

Device Description : When implemented together with CellaVision DM1200 and software, the CellaVision When implemented together with CellaVision DM1200 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Advanced RBC Application DM96 - 07350040973752 Catalog Number : CAR-960099

Device Description : When implemented together with CellaVision DM96 and software, the CellaVision Ad When implemented together with CellaVision DM96 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

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