Duns Number:251005005
Device Description: Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine.
Catalog Number
UTI-1S1
Brand Name
Rapid Response
Version/Model Number
UTI-1S1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063295,K063295
Product Code
JMT
Product Code Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Public Device Record Key
e9573913-9fb2-4f5e-92d3-9d948c5e9f4e
Public Version Date
July 06, 2018
Public Version Number
3
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 |