microbiology

• Microbiology

• Microbiological research

• Food microbiology

• Microbiology Devices:

• FR, May 18, 2011
• Proposed rules
• Food and Drug Administration

• Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

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.

• Federal Register Nbr. 76 FR 69034, November 07, 2011
• Proposed rules
• Health and Human Services Department

• Institute of Microbiology of the Chinese Academy of Sciences and TB Alliance Announce Partnership to Develop New Tuberculosis Drugs from Natural Sources.

Announcement precedes three-day ministerial meeting of high MDR-/XDR-TB burden countries in Beijing, April 1-3 BEIJING & NEW YORK -- The Institute o...

• Business Wire
• March 31, 2009

• Medical Devices; Immunology and Microbiology Devices:

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

• Immunology and Microbiology Devices:

• FR, August 09, 2011
• Rules
• Food and Drug Administration

• Science Notes / Microbiology, Biology

Wallabies low on methane Scientists have isolated a bacterium from the gut of Australian Tammar wallabies that allows them to consume and digest grasses, leaves and other plant material without producing copious amounts of methane, as cattle do.

• Buffalo News
• October 03, 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

• 42 CFR 493.821 - Condition: Microbiology.

• Code of Federal Regulations - Title 42: Public Health

• Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.

• Federal Register Nbr. 77 FR 16126, March 19, 2012
• Proposed rules
• Health and Human Services Department

• Immunology and Microbiology Devices:

• FR, September 28, 2010
• Proposed rules
• Food and Drug Administration