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news.Calypte Biomedical Corporation has announced that its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical, has received a permit to manufacture medical devices issued by the Beijing branch of the Chinese Food and Drug and Administration.
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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 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 for both the Chinese and international markets.
David Harris, CEO of Beijing Marr, said: “This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the drug division to the medical device division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our Aware HIV-1/2 OMT test once it has been approved for sale in China.”