AccessGUDID - DEVICE: AESKUSLIDES nDNA (Crithidia luciliae) (04250289510394)

GUDID

Device Identifier (DI) Information

Brand Name: AESKUSLIDES nDNA (Crithidia luciliae)
Version or Model: 53.100.US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289510394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. 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:	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?
55045	Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSW	Anti-Dna Antibody, Antigen And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172348	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: 78b592c6-aecb-4ad6-9e3f-add901736a7a
Public Version Date: May 28, 2025
Public Version Number: 3
DI Record Publish Date: May 14, 2018