Duns Number:051957769
Device Description: Ketone test strips - reagent strips for urinalysis
Catalog Number
1060
Brand Name
RELI-ON®
Version/Model Number
1060
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
08c49a1d-aeb7-4948-9be3-71b28fc70310
Public Version Date
August 02, 2021
Public Version Number
2
DI Record Publish Date
August 30, 2019
Package DI Number
10381131060505
Quantity per Package
24
Contains DI Package
00681131060431
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |