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01.31.2005

FDA clearance granted for drug screening product

American Bio Medica Corporation (ABMC) announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance on its Rapid TEC4 point of collection drug screen.
This is the third clearance that the company has received related to the Rapid TEC product line. The Rapid TEC products contain one individual drug-testing strip that includes the chemistry to detect more than one class of drug. These three clearances allow ABMC to provide its clinical customers with various configurations of 2 to 14 classes of drugs of abuse.
The company also announced that is has been granted another patent from the Canadian Intellectual Property Office. Patent Number 2,219,529, related to the company's Rapid Drug Screen product, covers a device for the collection, testing and shipment of body fluid samples.
This is the third patent granted this year to ABMC by the Canadian Intellectual Property Office. With this grant, ABMC's intellectual property portfolio for its drug of abuse testing line increases to 8 United States patents and 15 foreign patents, in addition to a number of pending patent applications both within the U.S. and internationally.

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