federal_register: 2011-28724

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-28724 Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection Proposed Rule The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the recommendation(s) of the panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. 2011-11-07 2011 11 https://www.federalregister.gov/documents/2011/11/07/2011-28724/microbiology-devices-classification-of-in-vitro-diagnostic-device-for-yersinia-species-detection https://www.govinfo.gov/content/pkg/FR-2011-11-07/pdf/2011-28724.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the...

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