Duns Number:075150847
Device Description: The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.IVD Research
Catalog Number
EIA-3444
Brand Name
Adenovirus Antigen (stool) ELISA
Version/Model Number
EIA-3444
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GNY
Product Code Name
ANTISERA, FLUORESCENT, ADENOVIRUS 1-33
Public Device Record Key
1b99bf7e-1b4a-4162-8ce1-8e74034706a0
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |