Calypte Biomedical Corporation says its Beijing China manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., a joint venture between Calypte and a Marr Group subsidiary, has successfully passed its quality system audit and obtained certification of its quality system to the international standard, ISO 13485:2003.
Certification was provided by TUV SUD Management Service GmbH. The ISO 13485:2003 standard specifically addresses the application of quality system principles to medical device products and is based on the ISO 9001:2000 quality management standard with many requirements specific to the medical device industry. Regulatory authorities in several countries around the world such as Health Canada, the European Union and elsewhere base their requirements for good manufacturing practices on the ISO quality standards. Conformance to the ISO standards is one of the many requirements for compliance with the European Union Medical Device and In Vitro Diagnostics Directives and obtaining CE Marking.
Beijing Marr Bio-pharmaceutical Co. was established by Calypte and its joint venture partner, Marr, to manufacture its Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for both the Chinese and international markets. The Aware HIV-1/2 OMT product is a rapid test that uses oral fluid for a diagnosis of HIV-1 or 2 infection in as little as 20 minutes with an accuracy comparable to U.S. FDA approved blood based laboratory HIV EIA tests.
Beijing Marr Bio-pharmaceutical Co. is currently manufacturing the Aware HIV-1/2 OMT product for export from China and this certification expands the number of countries to which the facility can export product. Beijing Marr Bio-pharmaceutical Co. is awaiting approval from the China State Food and Drug Administration to distribute and sell the product within China.