Avocet Medical, Inc. Receives IVDD CE Mark.Business Editors and Health/Medical Writers SAN JOSE, Calif.--(BW HealthWire)--Jan. 22, 2001 Avocet avocet (ăv`əsĕt), common name for a long-legged wading bird about 15 to 18 in. (37.5–45 cm) long, related to the snipe and belonging to the same family as the stilt. Medical, Inc. announced today that TUV (Technischer Überwachungs-Verein) Literally "Technical Watch-Over Association." A German certifying body involved with product safety for the European community. Rheinland has issued to them the CE Mark certificate under the European Union's In Vitro Diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. Directive for its AvoSure(TM) PT System for consumer prothrombin time Prothrombin Time Definition The prothrombin time test belongs to a group of blood tests that assess the clotting ability of blood. The test is also known as the pro time or PT test. self-testing. TUV Rheinland has confirmed that Avocet Medical, Inc. is the first United States company to receive the IVD (Interactive VideoDisc) See interactive video. Directive CE Mark from them. The AvoSure PT, designed for patient self-testing, offers added assurance to patients and their physicians by identifying patients out of the therapeutic range quickly as a result of more frequent testing. The AvoSure PT enables this more frequent testing by expanding patient's access to testing in their homes or while traveling. "We are delighted by this timely certification," said Matthew Collier, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Avocet Medical. "This certification demonstrates our dedication to providing our customers with the highest quality products and services. The CE Mark and ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001 certification were important corporate objectives for 2000." Certification organizations have only been officially recognized as notified bodies under the European Union's IVD Directive since October 2000. The European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community calls for these notified bodies to audit all but the low risk products covered by the IVD Directive. Avocet Medical's professional point-of-care use prothrombin time test system, AvoSure PT Pro+, falls under the self-certification category. The AvoSure PT Pro+ provides efficient monitoring of patients on oral anticoagulant therapy to the doctor's office or clinic where high quality prothrombin time test results are needed in a timely manner. In-office patients will benefit from the quick consultation that the doctor can provide now that the test results are available in just minutes and from the elimination of venous draws because the AvoSure PT Pro+ works with only a single drop of blood from a fingerstick. Avocet Medical is a private company that is dedicated to bringing the same benefits of improved patient outcomes, reduced overall costs and expanded access to testing for those patients at risk of stroke that the manufacturers of blood glucose monitors brought to diabetics. Avocet Medical intends to accomplish this through the development, production and sale of professional point-of-care and patient self-test diagnostic systems and solutions that advance the practice of anticoagulation therapy management. |
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