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Code of Federal Regulations (Last Updated: March 29, 2019) |
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Title 21 - Food and Drugs |
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CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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SUBCHAPTER H — MEDICAL DEVICES |
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Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES |
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Subpart D — Serological Reagents |
§ 866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
Latest version.
[79 FR 63036, Oct. 22, 2014