AccessGUDID - DEVICE: AESKUSLIDES ANCA Ethanol (04250289510356)

GUDID

Device Identifier (DI) Information

Brand Name: AESKUSLIDES ANCA Ethanol
Version or Model: 54.100.US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289510356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55061	Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172461	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
Special Storage Condition, Specify: 2-8°C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c93535b-32a8-442c-a9ac-4694306b3959
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 25, 2018