Duns Number:080028910
Device Description: Reagent Strips for Urinalysis: Ketone
Catalog Number
2881
Brand Name
KETOSTIX®
Version/Model Number
2881
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JIN
Product Code Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Public Device Record Key
bb73ba44-c08c-4ee2-88a4-0c77ee15f9b4
Public Version Date
January 21, 2020
Public Version Number
2
DI Record Publish Date
June 06, 2019
Package DI Number
40301932881216
Quantity per Package
12
Contains DI Package
00301932881218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper/case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |