Duns Number:341714388
Device Description: AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadi AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
Catalog Number
-
Brand Name
AESKULISA® DGP-A
Version/Model Number
3513
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132082
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
8e9f412b-94c8-4688-b3ce-26d98cd177ad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |