ARK™ Fentanyl II 0.5 ng/mL Assay
The ARK™ Fentanyl II 0.5 ng/mL Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 0.5 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers.
This in vitro diagnostic device is intended solely for use in employment and insurance testing.
| PRODUCT NO. | PRODUCT NAME | QUANTITY/KIT |
|---|---|---|
| 5072-0001-00 | ARK™ Fentanyl II 0.5 ng/mL Assay | R1 500mL, R2 500mL |
| 5052-0002-01 | ARK™ Fentanyl Calibrator | 2 x 10mL; Negative |
| 5052-0002-02 | ARK™ Fentanyl Calibrator | 2 x 10mL; Cutoff |
| 5052-0003-00 | ARK™ Fentanyl Control | 2 x 10mL; LOW 2 x 10mL; HIGH |
Package Inserts
- ARK™ Fentanyl II 0.5 ng/mL Assay Package Insert
- ARK™ Fentanyl 0.5 ng/mL Calibrator Package Insert
- ARK™ Fentanyl 0.5 ng/mL Control Package Insert
Safety Data Sheets
Regulatory Status
- United States — For Employment and Insurance Testing, 510(k) Exempt