AccessGUDID - DEVICE: Leica CytoVision Karyotyping review software (inc. dongle) (00849832003656)

GUDID

Device Identifier (DI) Information

Brand Name: Leica CytoVision Karyotyping review software (inc. dongle)
Version or Model: 23SWR000KXX001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 00849832003656
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: Leica CytoVision Karyotyping review software (incl. dongle)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42838	Laboratory analyser operation system software IVD	Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOY	DEVICE, AUTOMATED CELL-LOCATING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: fe67cdeb-0a3f-4686-a613-b908f383760e
Public Version Date: February 26, 2025
Public Version Number: 3
DI Record Publish Date: September 17, 2016