Duns Number:251005005
Device Description: Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative determination of Albumin and Creatinine in urine.
Catalog Number
U2.3-1S25
Brand Name
Rapid Response
Version/Model Number
U2.3-1S25
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
K061419,K061419
Product Code
JFY
Product Code Name
Enzymatic Method, Creatinine
Public Device Record Key
1172a376-bdb5-4200-853c-bda5419bf5b3
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
October 17, 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 |