Duns Number:251005005
Device Description: Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine.
Catalog Number
U5.3-1S100
Brand Name
Rapid Response
Version/Model Number
U5.3-1S100
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
K061559,K061559
Product Code
CEN
Product Code Name
Dye-Indicator, Ph (Urinary, Non-Quant.)
Public Device Record Key
a064c57e-8046-4ac4-ab64-8e919c3eec46
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
November 04, 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 |