Duns Number:961027315
Device Description: 2 ACR Urine StripMicroalbuminCreatinineFor Urine
Catalog Number
UA2ACR
Brand Name
CARDINAL HEALTH
Version/Model Number
UA2ACR
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
JFY
Product Code Name
ENZYMATIC METHOD, CREATININE
Public Device Record Key
a976d944-44e7-432b-93d6-ef40fdd0c4e7
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2020
Package DI Number
50885380175563
Quantity per Package
10
Contains DI Package
20885380175562
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 |