CellaVision DC-1

GUDID 07350040975091

Cellavision AB

Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated Cell morphology analyser IVD, automated/semi-automated

• Primary Device ID: 07350040975091
• NIH Device Record Key: ef9f9dad-d723-4c3f-8dac-528bf0af693d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellaVision DC-1
• Version Model Number: XU-10301
• Company DUNS: 508663101
• Company Name: Cellavision AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350040975091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200595

FDA Product Code

• JOY: Device, Automated Cell-Locating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-30
• Device Publish Date: 2020-10-22

Devices Manufactured by Cellavision AB

• 07350040975091 - CellaVision DC-1: 2020-10-30
• 07350040975091 - CellaVision DC-1: 2020-10-30
• 07350040975107 - CellaVision DC-1 PPA: 2020-10-30
• 07350040970201 - CellaVision® DM96: 2019-04-12 Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears.
• 07350040971277 - CellaVision® DM1200: 2019-04-12 Automated cell locating device. DM1200 automatically locates and presents images of blood cells on peripherall blood smears.
• 07350040972021 - Automated Digital Morphology Analyzer DI-60: 2019-04-12 Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears
• 07350040972304 - HemaPrep: 2019-04-12 Blood smear instrument
• 07350040972557 - CellaVision® Body Fluid Application DM1200: 2019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
• 07350040972564 - CellaVision® Body Fluid Application DM96: 2019-04-12 The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.