AccessGUDID - DEVICE: AESKULISA® DGP-Check (04250289503679)

GUDID

Device Identifier (DI) Information

Brand Name: AESKULISA® DGP-Check
Version or Model: 3515
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aesku.Diagnostics GmbH & Co. KG

Primary DI Number: 04250289503679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341714388 *Terms of Use

Device Description: AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).

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?
54812	Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MST	Antibodies, Gliadin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132082	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
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: b08dbbae-c3a2-44ac-9213-abca49a1f2c8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 27, 2016