Duns Number:164880598
Device Description: The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qualitative The ARK™ Ketamine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine on automated clinical chemistry analyzers.
Catalog Number
5056-0001-00
Brand Name
ARK™ Ketamine Assay
Version/Model Number
5056-0001-00
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
-
Product Code
DKZ
Product Code Name
Enzyme Immunoassay, Amphetamine
Public Device Record Key
6c764dfd-1c25-4f25-8f9d-361594296655
Public Version Date
July 31, 2019
Public Version Number
1
DI Record Publish Date
July 23, 2019
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 |