medical microbiology

• Medical Devices; Immunology and Microbiology Devices:

• FR, March 23, 2011
• Rules
• Food and Drug Administration

• Bruker and the Institute of Medical Microbiology at the University of Zurich Announce a Collaboration for Mass Spectrometry-based Microbial Identification with Focus on Coryneform Bacteria, Actinomycetes, Fastidious Gram-negative Rods and Moulds.

GENEVA -- At the 4th Congress of European Microbiologists (Federation of European Microbiological Societies, or FEMS) meeting in Geneva, Bruker announ...

• Business Wire
• June 27, 2011

• Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening the comment period for the notice announcing a public meeting for the ``Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public comments regarding matters to be discussed at the October 13, 2011, meeting, including the performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases. FDA is reopening the comment period to receive comment updates or any new information on the concept paper entitled ''Advancing Regulatory Scie...

• Federal Register Nbr. 76 FR 71982, November 21, 2011
• Notices
• Health and Human Services Department

• Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents

The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.

• Federal Register Nbr. 77 FR 14272, March 09, 2012
• Rules and Regulations
• Health and Human Services Department

• Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction

In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA) classified norovirus serological reagents into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices. The document published with inadvertent errors in the Analysis of Impacts section. This document corrects those errors.

• Federal Register Nbr. 77 FR 19534, April 02, 2012
• Rules and Regulations
• Health and Human Services Department

• Medical devices: Microbiology devices— Hepatitis A virus serological assays; reclassification,

• FR, February 09, 2006
• Rules
• Food and Drug Administration

• Medical Devices; Immunology and Microbiology Devices: Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay

• FR, October 09, 2009
• Rules
• Food and Drug Administration

• Medical, Immunology and Microbiology Devices: Classification of Enterovirus Nucleic Acid Assay

• FR, January 02, 2009
• Rules
• Food and Drug Administration

• Medical Devices; Immunology and Microbiology Devices: Classification of Plasmodium Species Antigen Detection Assays

• FR, May 20, 2008
• Rules
• Food and Drug Administration

• Medical devices: Immunology and microbiology devices— Cystic fibrosis transmembrane conductance regulator gene mutation detection system,

• FR, October 26, 2005
• Rules
• Food and Drug Administration