Duns Number:341714388
Device Description: AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadi AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
Catalog Number
7501US
Brand Name
AESKULISA® Glia-A
Version/Model Number
7501US
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
K052439
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
62f57b0e-e85d-4b77-9657-bce3ba817911
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 17, 2017
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 |