Device
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sig...
Manufacturer
Cellavision AB
Cellavision AB
Model: CRRS-SI0099
Catalog: CRRS-SI0099
DI: 07350040977194
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7117d19d-a3ca-43c5-9a4b-af274fc5db9b
Distribution Status:
In Commercial Distribution
DUNS Number:
508663101
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07350040977194
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43472
Name: Laboratory instrument/analyser application software IVD
Definition:
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).
FDA Product Codes
JOY
Device, Automated Cell-Locating
Premarket Submissions
Submission Number:
K092868
Supplement Number:
000