Duns Number:164880598
Device Description: The ARK™ Tramadol Assay is intended for the qualitative and/or semiquantitative determina The ARK™ Tramadol Assay is intended for the qualitative and/or semiquantitative determination of tramadol in human urine at a cutoff concentration of 100ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers.
Catalog Number
5040-0001-02
Brand Name
ARK™ Tramadol Assay (500mL)
Version/Model Number
5040-0001-02
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
K182280
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
ea89748a-f7d2-4f2e-91f0-b33b5781641c
Public Version Date
February 21, 2019
Public Version Number
1
DI Record Publish Date
January 21, 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 |