ARK™ EDDP Assay
The ARK™ EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 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 |
|---|---|---|
| 5051-0001-00 | ARK™ EDDP Assay | R1 28mL, R2 14mL |
| 5051-0001-01 | ARK™ EDDP Assay | R1 115mL, R2 58mL |
| 5051-0001-02 | ARK™ EDDP Assay | R1 500mL, R2 250mL |
| 5051-0002-00 | ARK™ EDDP Calibrator | 5 x 10mL |
| 5051-0002-01 | ARK™ EDDP Calibrator | 2 x 10mL; Negative |
| 5051-0002-02 | ARK™ EDDP Calibrator | 2 x 10mL; 100 ng/mL Cutoff |
| 5051-0002-03 | ARK™ EDDP Calibrator | 2 x 10mL; 300 ng/mL Cutoff |
| 5051-0003-00 | ARK™ EDDP Control | 2 x 10mL; LOW 75 ng/mL 2 x 10mL; HIGH 125 ng/mL |
| 5051-0003-01 | ARK™ EDDP Control | 2 x 10mL; LOW 225 ng/mL 2 x 10mL; HIGH 375 ng/mL |
Data Sheet
Package Inserts
Safety Data Sheets
Regulatory Status
- United States — 510(k) cleared
- Europe — CE Marked
- Canada — Medical device license