AccessGUDID - DEVICE: HEp-2000® IgG Fluorescent ANA-Ro Test System (M7492014RO101)

GUDID

Device Identifier (DI) Information

Brand Name: HEp-2000® IgG Fluorescent ANA-Ro Test System
Version or Model: 2014-Ro (10)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2014-Ro (10)
Company Name: IMMUNO CONCEPTS INC

Primary DI Number: M7492014RO101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038271904 *Terms of Use

Device Description: ANA-Ro 14 Well HEp-2000® Slides - 10 Slides

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
54809	Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3694a58-7f38-43e7-a808-bff3c61f7bcb
Public Version Date: June 04, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016