| 10867802000228 - mCup® | 2021-05-24 |
| 10867802000235 - mCup® | 2021-05-24 |
| 10867802000242 - mCup® | 2021-05-24 |
| 10867802000259 - mCup® | 2021-05-24 |
| 10867802000266 - mCup® | 2021-05-24 |
| 10867802000273 - xCupTM | 2021-05-24The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations:
Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL.
Configurations of the xCupTM may consist of any combination of the listed drug analytes.
The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. |
| 10867802000273 - xCupTM | 2021-05-24 The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, poin |
| 10867802000280 - eScreen eCup | 2021-05-24 The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid con |
| 00860429001022 - eREADER™ | 2020-05-04 The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providin |