Calypte to manufacture medical devices in China

Calypte Biomedical Corporation has received permission from Chinese authorities to manufacturing medical devices.

Calypte said its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical received the permission 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,"a company release said.

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 accuracy comparable to that of US FDA approved blood based laboratory HIV EIA tests.

Roger I. Gale, Calypte's President and Chief Executive Officer, 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."