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Bionano Genomics’ OEM partner obtains reagent class I registrations in China

Bionano Genomics announced that its Chinese original equipment manufacturing, or OEM, partner, A-smart MedTech, or A-smart, an assisted reproductive technology company, has obtained reagent class I registrations from China’s National Medical Products Administration, or NMPA, for Bionano’s DNA extraction kit and labeling products. A-smart is Bionano’s second Chinese OEM partner to obtain approval from NMPA for the Company’s optical genome mapping, or OGM, solutions. NMPA issued two approvals to A-smart: one for Bionano’s G2 direct label and stain, or DLS, DNA labeling kit and one for Bionano’s G2 SP bone marrow aspirate, or BMA, DNA isolation kit. A-smart received IVD Class I labels, enabling these reagents to be used for in vitro diagnostics in China.

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