Duns Number:176458115
Device Description: Liquid Controls ready to use for AimStrip® Urine Reagent Strips
Catalog Number
-
Brand Name
UA LIQUID CONTROLS 2X5ML
Version/Model Number
51115
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
JJW
Product Code Name
Urinalysis Controls (Assayed And Unassayed)
Public Device Record Key
1726ace9-3b26-4912-964a-6149d21f635e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 27, 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 | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |