Duns Number:045623154
Device Description: Pointe Scientific, Inc. Urine Chemistry Control Set is intended for use as a control for h Pointe Scientific, Inc. Urine Chemistry Control Set is intended for use as a control for human urine assay methods.6 x 10 ml.
Catalog Number
P7582-CTL
Brand Name
Pointe Scientific, Inc. Urine Chemistry Controls
Version/Model Number
P7582-CTL
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
K831526
Product Code
JJW
Product Code Name
Urinalysis Controls (Assayed And Unassayed)
Public Device Record Key
fd3564b4-48df-45d7-9f2e-e743e003afdc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |