Dade Behring has received 510K clearance for the Emit II Plus Ecstasy Assay. The assay screens urine for the following illegal substances: methylenedioxymethamphetamine (MDMA, or Ecstasy), methylenedioxyethylamphetamine (MDEA) and methylenedioxyamphetamine (MDA). It complies with proposed SAMSHA (Substance Abuse and Mental Health Services Administration) and European regulations and has approved applications for use on the Olympus AU400/AU600/AU2700/AU5400 systems and the Syva 30R Analyser.
The Emit II Plus Ecstasy Assay meets laboratory demand for an Ecstasy-specific test that includes a 500 ng/mL cutoff level to satisfy, in part, the proposed SAMHSA drug testing guidelines. The assay is intended to be used as a standalone test or in conjunction with the Emit II Plus Amphetamines Assay, which detects MDMA at higher levels than does this Ecstasy-specific test.
The Emit II Plus Ecstasy Assay is a convenient, ready-to-use liquid assay based on the gold-standard Emit II Plus chemistry. The assay offers laboratories a variety of solutions depending on their needs. It can be used at the 300 ng/mL or 500 ng/mL cutoff level for qualitative or semiquantitative determination. Reagents are offered in two kit sizes to accommodate both low- and high-volume laboratories.
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