AccessGUDID - DEVICE: ImmunoDOT Autoimmunity Panel 1 (00613745051253)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoDOT Autoimmunity Panel 1
Version or Model: 800-5125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5125
Company Name: Genbio

Primary DI Number: 00613745051253
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.

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?
54810	Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K896347	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 tests

Device Record Status

Public Device Record Key: 23a39de6-933a-4183-93ab-a124453ac9b4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016