Duns Number:251005005
Device Description: Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for th Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine.
Catalog Number
U-KET-1S100
Brand Name
Rapid Response
Version/Model Number
U-KET-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
JIN
Product Code Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Public Device Record Key
362b582c-d2be-4dfc-bc4e-9f229ca9d488
Public Version Date
July 06, 2018
Public Version Number
3
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 |