For DI Body Fluid Application AG241722

GUDID 07350040974704

The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.

Cellavision AB

Laboratory instrument/analyser application software IVD
Primary Device ID07350040974704
NIH Device Record Key3cf89a67-762d-49ed-a7a6-d35d8ac482ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameFor DI Body Fluid Application
Version Model NumberAG241722
Catalog NumberAG241722
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
GS107350040974704 [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 Date2016-09-20

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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