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ALFA Scientific Designs, Inc. Receives FDA OTC-CLIA Clearance for Product Line Additions Oxycodone and Morphine/Opiate


7/14/2010 12:36:02 PM

Alfa Scientific (Poway, California) announced today that it expanded its portfolio of OTC-CLIA Cleared drug of abuse tests, adding Oxycodone (100 ng/mL and 300 ng/mL) and Morphine/Opiate (300 ng/mL) to its existing product range.

In all, Alfa offers the following fourteen OTC-CLIA Cleared parameters:

Drug Analyte Cut Off Level Status AMP - Amphetamine 1000 ng/mL OTC-Cleared & CLIA-Waived BAR - Barbiturate 200 ng/mL OTC-Cleared & CLIA-Waived BZD - Benzodiazepeine 300 ng/mL OTC-Cleared & CLIA-Waived COC - Cocaine 300 ng/mL OTC-Cleared & CLIA-Waived MET - Methamphetamine 1000 ng/mL OTC-Cleared & CLIA-Waived MOR/OPI - Morphine/Opiate 2000 ng/mL OTC-Cleared & CLIA-Waived MOR/OPI300 - Morphine/Opiate 300 ng/mL OTC-Cleared (Complexity: Waived) MTD - Methadone 300 ng/mL OTC-Cleared & CLIA-Waived OXY – Oxycodone 100 ng/mL OTC-Cleared (Complexity: Waived) OXY300 – Oxycodone 300 ng/mL OTC-Cleared (Complexity: Waived) PCP - Phencyclidine 25 ng/ml OTC-Cleared & CLIA-Waived TCA - Tricyclic Antidepressant 1000 ng/mL OTC-Cleared & CLIA-Waived THC - Marijuana 50 ng/mL OTC-Cleared & CLIA-Waived XTC - Ecstasy/MDMA 500 ng/mL OTC-Cleared & CLIA-Waived

Cleared by the US FDA these OTC-CLIA products can be sold to CLIA-Waived facilities (in addition to the over-the-counter market). These tests are available in multi-drug dip cards, integrated cups, and single dip cassette formats. This greatly expands the potential market for these tests in laboratory settings, as a December 2008 CMS survey showed that over 60% of laboratories registered in CLIA-applicable states were certified under this categorization, while only a fraction of laboratory tests have been cleared for their use.

For more information on our drug screening tests please contact us today.

About Alfa Scientific Designs, Inc.

Alfa Scientific Designs, Inc. is located in Poway, CA, and is a manufacturer and distributor of US made rapid diagnostic tests for Drugs of Abuse, Infectious Disease, Cardiac Markers, and Fertility. Alfa offers a variety of testing formats as well as OEM custom manufacturing capabilities.


Read at BioSpace.com

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