Duns Number:878252071
Device Description: Diagnostic Automation Inc. URS-2P (100 Strips Bottle) for the semi-quantitative and qualit Diagnostic Automation Inc. URS-2P (100 Strips Bottle) for the semi-quantitative and qualitative detection of Glucose and Protein in Urine.
Catalog Number
URS-2P (100)
Brand Name
InstaTest
Version/Model Number
URS-2P (100)
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
-
Product Code
JIL
Product Code Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Public Device Record Key
0b9169a1-4a09-48d1-a00f-f5b1832c955d
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 23, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |