AccessGUDID - DEVICE: AESKULISA® dsDNA-G (04250289500647)

GUDID

Device Identifier (DI) Information

Brand Name: AESKULISA® dsDNA-G
Version or Model: 3142
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289500647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).

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

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

GMDN Preferred Term Name	GMDN Definition
Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041628	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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40511a2d-fc0d-4b0e-b1ea-9c5ece4ab3d5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 27, 2016