Duns Number:341714388
Device Description: The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitativ The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.
Catalog Number
7504US
Brand Name
AESKULISA tTg-G New Generation
Version/Model Number
7504US
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
K042644
Product Code
MVM
Product Code Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Public Device Record Key
d84f4b02-1240-4f27-909b-e66bf1f6e1d4
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 |