Regulations.gov document

Microbiology Devices; Reclassification of Cytomegalovirus Doxyribonucleic Acid…

Proposed Rule · FDA-2016-N-2880 · posted Sep 18, 2020

Key facts

Document ID FDA-2016-N-2880-0004
Title Microbiology Devices; Reclassification of Cytomegalovirus Doxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management
Document type Proposed Rule
Subtype Request for Comment
Agency FDA
Docket FDA-2016-N-2880
Posted Sep 18, 2020
Federal Register citation 85 FR 58300
FR document number 2020-20716
CFR 21 CFR Part 866
Comment period opens Sep 18, 2020
Comments due Nov 18, 2020
Effective date Sep 18, 2020

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