Duns Number:878252071
Device Description: AccuDiag ™ Gliadin IgGMultiple Coeliac disease-associated antibody IVD, kit, enzyme immuno AccuDiag ™ Gliadin IgGMultiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)AccuDiag ™ Gliadin IgG ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The Test System is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.
Catalog Number
1021-2
Brand Name
AccuDiag ™
Version/Model Number
DACD-1021-2
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
-
Product Code
MST
Product Code Name
Antibodies, Gliadin
Public Device Record Key
783920ca-59ca-474f-aab8-731fb4c55210
Public Version Date
August 16, 2021
Public Version Number
1
DI Record Publish Date
August 06, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |