For DI Remote Review Software version 5.0.x BC188562

GUDID 07350040974728

The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.

Cellavision AB

Laboratory instrument/analyser application software IVD
Primary Device ID07350040974728
NIH Device Record Key8b111f0a-5a07-4dcc-bc38-aa852e6f85bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFor DI Remote Review Software version 5.0.x
Version Model NumberBC188562
Catalog NumberBC188562
Company DUNS508663101
Company NameCellavision AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se
Phone+46464601600
Emailservice@cellavision.se

Device Identifiers

Device Issuing AgencyDevice ID
GS107350040974728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOYDevice, Automated Cell-Locating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-12
Device Publish Date2016-09-23

Devices Manufactured by Cellavision AB

07350040975091 - CellaVision DC-12020-10-30
07350040975107 - CellaVision DC-1 PPA2020-10-30
07350040970201 - CellaVision® DM962019-04-12 Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears.
07350040971277 - CellaVision® DM12002019-04-12 Automated cell locating device. DM1200 automatically locates and presents images of blood cells on peripherall blood smears.
07350040972021 - Automated Digital Morphology Analyzer DI-602019-04-12 Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears
07350040972304 - HemaPrep2019-04-12 Blood smear instrument
07350040972557 - CellaVision® Body Fluid Application DM12002019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
07350040972564 - CellaVision® Body Fluid Application DM962019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.

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