CellaVision® Advanced RBC Application DM9600

Basic Information

• Brand Name: CellaVision® Advanced RBC Application DM9600
• Primary DI: 07350040973769
• Version / Model: CAR-970099
• Catalog Number: CAR-970099
• Company Name: Cellavision AB
• Labeler DUNS: 508663101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-05
• Public Version: 4
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: 3460c27f-b631-40d3-8878-b46bed3a9c33

Device Description

When implemented together with CellaVision DM9600 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 Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOY	Device, Automated Cell-Locating	Hematology	864.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350040973769	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171315	000