federal_register: 2012-6518

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2012-6518 Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis. 2012-03-19 2012 3 https://www.federalregister.gov/documents/2012/03/19/2012-6518/microbiology-devices-reclassification-of-nucleic-acid-based-systems-for-mycobacterium-tuberculosis https://www.govinfo.gov/content/pkg/FR-2012-03-19/pdf/2012-6518.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special...  

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