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並前往https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211079

510(k) Premarket Notification - Accessdata.fda.gov - US Food ...

Device Classification Name, respiratory specimen nucleic acid sars-cov-2 test 22. 510(k) Number, K211079. Device Name, BioFire COVID-19 Test ...

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