Duns Number:251005005
Device Description: Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection of various adenovirus in fecal samples.
Catalog Number
ADE-9C20
Brand Name
Rapid Response
Version/Model Number
ADE-9C20
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
K990630,K990630
Product Code
GOD
Product Code Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Public Device Record Key
c2c83379-0266-4f1b-a1bf-73d23e64aa7f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 25, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |