AccessGUDID - DEVICE: Leica Biosystems CytoVision Karyotyping Station w/Jai MV4 Camera (00849832003373)

GUDID

Device Identifier (DI) Information

Brand Name: Leica Biosystems CytoVision Karyotyping Station w/Jai MV4 Camera
Version or Model: 23CAP001KXX001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 00849832003373
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 Biosystems CytoVision Karyotyping Station w/Jai MV4 Camera

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?
61864	Cell morphology analyser IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.	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: db9d0318-5276-432e-859b-df7c23f6b9d9
Public Version Date: February 26, 2025
Public Version Number: 4
DI Record Publish Date: September 17, 2016