Duns Number:010558476
Device Description: 96 well ELISA for the detection of IgA Gliadin antibodies in human serum
Catalog Number
-
Brand Name
Autostat II Anti-Gliadin IgA
Version/Model Number
FGA20
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
K993086
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
52194d3a-c8a8-424a-9399-27c66bcd6398
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 158 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 148 |