Duns Number:164880598
Device Description: The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK™ Oxcarbazepine Metabolite Assay.
Catalog Number
5032-0003-00
Brand Name
ARK™ Oxcarbazepine Metabolite Control
Version/Model Number
5032-0003-00
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
K153596
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
b656cb64-f90e-4c7a-a600-681e1c5bcbf1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| U | Unclassified | 4 |