Duns Number:961027315
Device Description: MONO II RAPID TEST
Catalog Number
CH1145
Brand Name
CARDINAL HEALTH
Version/Model Number
CH1145
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KTN
Product Code Name
SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
Public Device Record Key
d9b8df8e-6d8d-431b-b87a-659fe7db4fdb
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 14, 2016
Package DI Number
50885380057418
Quantity per Package
18
Contains DI Package
20885380057417
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |