Calypte Biomedical Corporation's Chinese Manufacturing Subsidiary Obtains Medical Device Manufacturing Permit
Published: Jan 10, 2008
PORTLAND, Ore.--(BUSINESS WIRE)--Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., (“Beijing Marr”), has received a permit to manufacture medical devices issued by the Beijing branch of the Chinese Food and Drug and Administration. The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within the country. Beijing Marr is currently awaiting approval from the China State Food and Drug Administration (SFDA) to distribute and sell Calypte’s Aware™ HIV-1/2 OMT rapid diagnostic test within China.