Duns Number:119214195
Device Description: Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several differe Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Catalog Number
-
Brand Name
Detector UA 2
Version/Model Number
IDU-2PG
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
K955438,K955438,K955438
Product Code
JIL
Product Code Name
METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
Public Device Record Key
17bdf112-a948-4e2c-b07e-89a2e984ab6a
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 25, 2016
Package DI Number
20722355002181
Quantity per Package
12
Contains DI Package
10722355002245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |