Duns Number:341714388
Device Description: AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum.30'+30'+30' automation incubation.
Catalog Number
30-7515US
Brand Name
AESKULISA® DGP-Check
Version/Model Number
30-7515US
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
5d736be5-e96a-4c04-bd0b-4d86abb935fe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 01, 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 |