Calypte Biomedical Corporation, a developer, manufacturer and marketer of HIV diagnostic tests, says its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Company, 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 to distribute and sell Calypte's Aware HIV-1/2 OMT rapid diagnostic test within China.
Beijing Marr, a joint venture between Calypte and a Marr Group subsidiary was established to manufacture Calypte's 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 using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.
Roger I. Gale, Calypte's president and CEO, commented, "Coming on the heels of the recent ISO 13485 Certification of Beijing Marr's manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market."