AccessGUDID - DEVICE: Image Navigator® (M74900IN2201)

GUDID

Device Identifier (DI) Information

Brand Name: Image Navigator®
Version or Model: IN220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IN220
Company Name: IMMUNO CONCEPTS INC

Primary DI Number: M74900IN2201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038271904 *Terms of Use

Device Description: Automated microscope system for immunofluorescent determination of autoantibodies.

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
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160265	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: 49fd4657-1539-4227-afbc-2b21fa82ca88
Public Version Date: June 06, 2025
Public Version Number: 7
DI Record Publish Date: April 08, 2019