The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 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
5069-0001-00	ARK™ Fentanyl II Assay	R1 28mL, R2 28mL
5069-0001-01	ARK™ Fentanyl II Assay	R1 115mL, R2 115mL
5069-0001-02	ARK™ Fentanyl II Assay	R1 500mL, R2 500mL
5031-0002-01	ARK™ Fentanyl Calibrator	2 x 10mL; Negative
5031-0002-02	ARK™ Fentanyl Calibrator	2 x 10mL; Cutoff
5031-0003-00	ARK™ Fentanyl Control	2 x 10mL; LOW 2 x 10mL; HIGH

Data Sheet

ARK™ Fentanyl II Assay Data Sheet

Package Inserts

ARK™ Fentanyl II Assay Package Insert
- English
- French
- German
- Italian
- Latvian
- Portuguese
- Slovak
- Spanish
- Swedish
ARK™ Fentanyl Calibrator Package Insert
- English
- French
- German
- Italian
- Latvian
- Portuguese
- Slovak
- Spanish
- Swedish
ARK™ Fentanyl Control Package Insert
- English
- French
- German
- Italian
- Latvian
- Portuguese
- Slovak
- Spanish
- Swedish

Safety Data Sheets

Regulatory Status

United States — 510(k) cleared
Europe — CE Marked
Canada — Medical device licence