AccessGUDID - DEVICE: DIASTAT anti-Jo-1 (07340058410479)

GUDID

Device Identifier (DI) Information

Brand Name: DIASTAT anti-Jo-1
Version or Model: FAJO200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FAJO200
Company Name: Euro-Diagnostica AB

Primary DI Number: 07340058410479
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559894501 *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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Jo-1 antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.

FDA Product Code

[?]

Product Code	Product Code Name
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912292	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: 360f91fd-57ea-40f4-ba0d-a29d13fcb210
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 12, 2016