federal_register: 2014-12544

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-12544 Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens Rule The Food and Drug Administration (FDA) is reclassifying 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). FDA is also issuing the special controls guideline entitled "Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens." These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis. 2014-05-30 2014 5 https://www.federalregister.gov/documents/2014/05/30/2014-12544/microbiology-devices-reclassification-of-nucleic-acid-based-systems-for-mycobacterium-tuberculosis https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/2014-12544.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is reclassifying 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...

Links from other tables