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ABMC Receives FDA 510k Clearance for New Rapid Tec-R- 3 And Rapid Tec 4 Tests; Products Incorporate Tests for Methamphetamines, Opiates at 300 ng Cutoff.


Business Editors

KINDERHOOK, N.Y.--(BUSINESS WIRE)--June 2, 2003

American Bio Medica medica (māˑ·dē·k  Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABMC ABMC American Battle Monuments Commission
ABMC Alexian Brothers Medical Center (Illinois)
ABMC Aviation Battle Management Concept
ABMC Arrowbear Music Camp (California) 
) today announced that it has received 510(k) clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for new tests in its Rapid Tec(R) product series that include assays for methamphetamines and opiates Opiates
Analgesic, pain killing drugs, such as heroin and morphine that depress the central nervous system.

Mentioned in: Withdrawal Syndromes
 at a 300 ng cutoff level.

The company also launched Rapid Tec 5, which tests for THC THC tetrahydrocannabinol.

THC
n.
Tetrahydrocannabinol; a compound that is obtained from cannabis or is made synthetically; it is the primary intoxicant in marijuana and hashish.
, cocaine, amphetamines Amphetamines
Sympathomimetic amines; sometimes called speed; synthetic chemicals that stimulate the central nervous system.

Mentioned in: Weight Loss Drugs

amphetamines
, benzodiazepines Benzodiazepines Definition

Benzodiazepines are medicines that help relieve nervousness, tension, and other symptoms by slowing the central nervous system.
Purpose

Benzodiazepines are a type of antianxiety drugs.
, and opiates (300 ng), for forensic use.

These FDA clearances are the latest in a string of new product approvals for ABMC, which is broadening its technological base to offer more specific and flexible drug testing solutions to meet customer needs.

"We saw a specific market need for an expanded menu of drug tests to include methamphetamines and opiate opiate /opi·ate/ (o´pe-it)
1. any drug derived from opium.

2. hypnotic (2).


o·pi·ate
n.
1.
 detection at 300 ng cutoff levels, and we have the in-house ability to develop products to meet these needs," said Gerald A. Moore, chairman and chief executive officer of ABMC. "ABMC is carving out a leading market position by offering a wider range of tests, and also offering the flexibility to combine various tests to meet the exact needs of different programs."

Rapid Tec is one of ABMC's most successful products, offering the chemistry to detect more than one class of drug on a single drug testing strip. The product is used throughout the world, particularly in workplace and law enforcement applications.

The Company also announced that it has launched a new on-line training module specifically for the Rapid Tec series. To access the Rapid Tec training, or for more information on ABMC's drug testing products please visit www.abmc.com.

About American Bio Medica Corporation

American Bio Medica Corporation is a biotechnology company that develops manufactures and markets accurate, cost-effective immunoassay diagnostic test kits, including some of the world's most effective on-site drugs of abuse tests. The company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets. ABMC's Rapid Drug Screen(R), Rapid One(R), Rapid Tec and Rapid Tec Cup(TM) test for the presence or absence of drugs of abuse in urine, while OralStat(R) tests for the presence or absence of drugs of abuse in saliva. ABMC was recently named among the 2002 Deloitte & Touche Technology Fast 500, a listing of the fastest-growing technology companies in North America.

This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, the following: continued acceptance of the Company's products, increased levels of competition in our industry, the acceptance of new products, inherent risks associated with product development and intellectual property rights, the Company's dependence on key personnel, third party sales and suppliers. There can be no assurance that the Company will be successful in addressing such risks and uncertainties. Investors are strongly encouraged to review the section entitled "Risk Factors" in the Company's annual report on Form 10-KSB for the fiscal year ended December 31, 2002, and quarterly reports on Form 10-QSB on file with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect operating results and the market price of the Company's common shares.
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Publication:Business Wire
Geographic Code:1USA
Date:Jun 2, 2003
Words:543
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