Duns Number:010717890
Device Description: The Dropper Urine Chemistry Control is intended for use as a control for human urine assay The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.
Catalog Number
1430-01
Brand Name
Dropper Urine Chemistry Control Level 1&2 Set 2x10mL
Version/Model Number
1430-01
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K831526
Product Code
JJW
Product Code Name
Urinalysis Controls (Assayed And Unassayed)
Public Device Record Key
c7291c89-8f9f-4b2a-b152-79fb89c110b9
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 2018
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. | 5 |