Duns Number:024824641
Catalog Number
ADN-3110
Brand Name
Adenovirus Negative Control
Version/Model Number
ADN-3110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 30, 2017
Issuing Agency
In HIBCC
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
-
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
b16e0c84-30d7-4dfb-914c-e0c267191010
Public Version Date
March 04, 2020
Public Version Number
3
DI Record Publish Date
September 12, 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 | 68 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |