Oxford Immunotec announces successful re-registration of the T-SPOT®.TB test in China
OXFORD IMMUNOTEC GLOBAL PLC OR (OXFD)
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Source: GlobeNewswire
OXFORD, United Kingdom and MARLBOROUGH, Mass., April 21, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD), a global, high-growth diagnostics company, today announced that it has successfully obtained re-registration of the T-SPOT.TB test in China. The re-registration was granted by the Chinese National Medical Products Administration (NMPA) on April 13, 2020 and, as is customary, the registration lasts until April 12, 2025 whereupon it will need to be renewed. As a Class III medical device, China’s Medical Device Registration Regulations and subsequent policies require that the company apply to the Center for Medical Device Evaluation (“CMDE”) of the National Medical Products Administration (“NMPA”) to renew its license for the T-SPOT.TB test every five years. The latest re-registration follows a significant review by the NMPA, and an overseas site inspection of the company’s Oxford, UK manufacturing facility. Since first receiving approval in 2010, and its fir
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