CellaVision DC-1

GUDID 07350040975091

Cellavision AB

Cell morphology analyser IVD, 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.