AccessGUDID - DEVICE: FIDIS (03760170782010)

GUDID

Device Identifier (DI) Information

Brand Name: FIDIS
Version or Model: Vasculitis
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MX 507
Company Name: THERADIAG SA

Primary DI Number: 03760170782010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 391123478 *Terms of Use

Device Description: Simultaneous detection kit of anti-myeloperoxidase, anti-proteinase 3 and anti-glomerular basement membrane antibodies.

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?
54855	Multiple vasculitis-associated antibody IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple antibodies associated with vasculitis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3).	Obsolete	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 119b613d-a07b-4071-8bb0-9c44e709b20e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 01, 2016