ARK™ Tramadol Assay
The ARK™ Tramadol Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of tramadol in human urine at a cutoff concentration of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
| PRODUCT NO. | PRODUCT NAME | QUANTITY/KIT |
|---|---|---|
| 5040-0001-00 | ARK™ Tramadol Assay | R1 28mL, R2 14mL |
| 5040-0001-01 | ARK™ Tramadol Assay | R1 115mL, R2 58mL |
| 5040-0001-02 | ARK™ Tramadol Assay | R1 500mL, R2 250mL |
| 5040-0002-00 | ARK™ Tramadol Calibrator | 5 x 10mL |
| 5040-0002-01 | ARK™ Tramadol Calibrator | 2 x 10mL; Negative |
| 5040-0002-02 | ARK™ Tramadol Calibrator | 2 x 10mL; 100 ng/mL Cutoff |
| 5040-0003-00 | ARK™ Tramadol Control | 2 x 10mL; LOW 75 ng/mL 2 x 10mL; HIGH 125 ng/mL |
Data Sheet
Package Inserts
- ARK™ Tramadol Assay Package Insert
- ARK™ Tramadol Calibrator Package Insert
- ARK™ Tramadol Control Package Insert
Safety Data Sheets
Regulatory Status
- United States — 510(k) cleared
- Europe — CE Marked
- Canada — Medical device license