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 Code of Federal Regulations (Last Updated: March 29, 2019)
 Title 21 - Food and Drugs
 CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
 SUBCHAPTER H — MEDICAL DEVICES
 Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
 Subpart E — Immunology Laboratory Equipment and Reagents

  § 866.4520 Immunofluorometer equipment.  


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  • Related Notices
    • 2019-06026. Final rule. 2019-06026. Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
    • 2019-04719. Final order. 2019-04719. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens
    • 2018-22694. Final order. 2018-22694. Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel
    • 2018-13406. Final order. 2018-13406. Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test
    • 2018-12760. Final order. 2018-12760. Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
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[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001

                    
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