Duns Number:164880598
Device Description: The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitat The ARK™ Lamotrigine Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with Lamotrigine. The ARK™ Lamotrigine Assay consists of reagents RI anti-Lamotrigine polyclonal antibody with substrate and R2 Lamotrigine epitope labeled with bacterial G6PDH enzyme.
Catalog Number
5023-0001-00
Brand Name
ARK™ Lamotrigine Assay
Version/Model Number
5023-0001-00
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
K101305
Product Code
ORH
Product Code Name
Lamotrigine Assay
Public Device Record Key
acecd279-3c9f-4a56-a97a-cd0dae5e3f94
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 |