AccessGUDID - DEVICE: AESKUSLIDES® ANA-HEp-2 (04250289504461)

GUDID

Device Identifier (DI) Information

Brand Name: AESKUSLIDES® ANA-HEp-2
Version or Model: 51.100.US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51.100.US
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289504461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKUSLIDES ANA HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA HEp-2 Test System is intended for use as aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

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):	Yes
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?
54808	Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay	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 a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120889	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: f69056ba-1faf-4c15-b188-f37b3b64ee42
Public Version Date: May 28, 2025
Public Version Number: 4
DI Record Publish Date: February 28, 2017