AccessGUDID - DEVICE: GenASIs™ System (07290016630015)

GUDID

Device Identifier (DI) Information

Brand Name: GenASIs™ System
Version or Model: GenASIs
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APPLIED SPECTRAL IMAGING LTD.

Primary DI Number: 07290016630015
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 600741763 *Terms of Use

Device Description: No description.

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):	No
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
NOT	Microscope, Automated, Image Analysis, Operator Intervention
NQN	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
LNJ	Analyzer, Chromosome, Automated
NTH	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012103	000
K050236	000
K071398	000
K101291	000
K110345	000
K122554	000
K140957	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1693f20-471e-4e7d-9581-5c4800a4d0b9
Public Version Date: March 22, 2022
Public Version Number: 4
DI Record Publish Date: January 25, 2018