ARK™ Hydrocodone Assay
The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/ tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures.
| PRODUCT NO. | PRODUCT NAME | QUANTITY/KIT |
|---|---|---|
| 5076-0001-00 | ARK™ Hydrocodone Assay | R1 28mL, R2 14mL |
| 5076-0001-01 | ARK™ Hydrocodone Assay | R1 115mL, R2 58mL |
| 5076-0001-02 | ARK™ Hydrocodone Assay | R1 500mL, R2 250mL |
| 5076-0002-00 | ARK™ Hydrocodone Calibrator | 5 x 10mL |
| 5076-0002-01 | ARK™ Hydrocodone Calibrator | 2 x 10mL; Negative |
| 5076-0002-02 | ARK™ Hydrocodone Calibrator | 2 x 10mL; 300 ng/mL Cutoff |
| 5076-0003-00 | ARK™ Hydrocodone Control | 2 x 10mL; LOW 225 ng/mL 2 x 10mL; HIGH 375 ng/mL |
Data Sheet
Package Inserts
- ARK™ Hydrocodone Assay Package Insert
- ARK™ Hydrocodone Calibrator Package Insert
- ARK™ Hydrocodone Control Package Insert
Safety Data Sheets
Regulatory Status
- United States — 510(k) cleared