id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2011-N-0103-0025,FDA,FDA-2011-N-0103,Reference 6 Specific Identification of Bacillus anthracis,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:03Z,,0,0,0900006483b53a23 FDA-2011-N-0103-0023,FDA,FDA-2011-N-0103,Reference 8 Phage Isolated from Lysogenic Bacillus anthracis,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:01Z,,0,0,0900006483b53a25 FDA-2011-N-0103-0028,FDA,FDA-2011-N-0103,Reference 3 Regulatory Flexibility Analysis,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:05Z,,0,0,0900006483b53976 FDA-2011-N-0103-0026,FDA,FDA-2011-N-0103,Reference 5 Production and Validation of the Use of Gamma Phage,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:04Z,,0,0,0900006483b53978 FDA-2011-N-0103-0027,FDA,FDA-2011-N-0103,Reference 4 Abshire T.G. et at Validation ofthe use of gamma phage for identifying Bacillus anthracis,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:04Z,,0,0,0900006483b53977 FDA-2011-N-0103-0024,FDA,FDA-2011-N-0103,Reference 7 Differential Diagnosis of Bacillus cereus,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:02Z,,0,0,0900006483b53a24 FDA-2011-N-0103-0030,FDA,FDA-2011-N-0103,Reference 1 Class II Special Controls Guideline,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:06Z,,0,0,0900006483b53974 FDA-2011-N-0103-0031,FDA,FDA-2011-N-0103,Index to References FR,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:07Z,,0,0,0900006483b53d58 FDA-2011-N-0103-0029,FDA,FDA-2011-N-0103,Reference 2 Transcript of the FDA Microbiology Devices Panel Meeting March 7 2002,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:06Z,,0,0,0900006483b53975 FDA-2011-N-0103-0021,FDA,FDA-2011-N-0103,Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection,Rule,Final Rule,2019-04-01T04:00:00Z,2019,4,2019-04-01T04:00:00Z,,2019-04-01T15:56:15Z,2019-06026,0,0,0900006483b512a0 FDA-2011-N-0103-0022,FDA,FDA-2011-N-0103,Reference 9 A colour Atlas of Bacillus Species,Supporting & Related Material,Background Material,2019-04-01T04:00:00Z,2019,4,,,2019-04-01T16:17:00Z,,0,0,0900006483b53a26 FDA-2011-N-0103-0016,FDA,FDA-2011-N-0103,Reference 6 - Phage Isolated From Lysogenic Bacillus Anthracis,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:37Z,,0,0,0900006481e03459 FDA-2011-N-0103-0017,FDA,FDA-2011-N-0103,Reference 7 - A Colour Atlas of Bacillus Species,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:45Z,,0,0,0900006481e0345a FDA-2011-N-0103-0018,FDA,FDA-2011-N-0103,Reference 8 - Draft Guideline for Industry and FDA Staff Class II Special Controls Guidline: In Vitro Diagnostic Devices for Bacillus spp. Detection,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:51Z,,0,0,0900006481e0345e FDA-2011-N-0103-0015,FDA,FDA-2011-N-0103,Reference 5 - Differential Diagnosis of Bacillus Cereus Bacillus Anthracis and Bacillus Cereus Var. Mycoides,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:33Z,,0,0,0900006481e032e5 FDA-2011-N-0103-0012,FDA,FDA-2011-N-0103,Reference 2 - Validation of the use of Gamma Phage for Identifying Bacillus Anthracis,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:19Z,,0,0,0900006481e032b1 FDA-2011-N-0103-0014,FDA,FDA-2011-N-0103,Reference 4 - Specific Identification of Bacillus Anthracis by Means of a Variant Bacteriophage,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:29Z,,0,0,0900006481e032e4 FDA-2011-N-0103-0011,FDA,FDA-2011-N-0103,Reference 1 - Transcript of Microbiology Devices Panel meeting March 7 2002,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:15Z,,0,0,0900006481e02ead FDA-2011-N-0103-0010,FDA,FDA-2011-N-0103,List of References,Supporting & Related Material,List,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:10Z,,0,0,0900006481e031a7 FDA-2011-N-0103-0013,FDA,FDA-2011-N-0103,Reference 3 - Production and Validation of the Use of Gamma Phage for the Identification of Bacillus Anthracis,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:25Z,,0,0,0900006481e032b2 FDA-2011-N-0103-0019,FDA,FDA-2011-N-0103,"Reference 9 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection - Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis",Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:39:55Z,,0,0,0900006481e0345f FDA-2011-N-0103-0020,FDA,FDA-2011-N-0103,Reference 10 - Laboratory Response Network LRN Level A laboratory procedures for identification of Bacillus Anthracis,Supporting & Related Material,Background Material,2016-01-12T05:00:00Z,2016,1,,,2016-01-12T18:40:02Z,,0,0,0900006481e034a8 FDA-2011-N-0103-0008,FDA,FDA-2011-N-0103,Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-11-17T05:00:00Z,2015,11,2015-11-17T05:00:00Z,2016-02-17T04:59:59Z,2015-12-10T22:00:47Z,2015-29275,0,0,0900006481d4d5ce FDA-2011-N-0103-0004,FDA,FDA-2011-N-0103,"Reference 2 - Abshire, T.G. et at, ""Validation ofthe use of gamma phage for identifying Bacillus anthracis,It 102nd American Society for Microbiology Annual Meeting poster #C 122, 2001 [5/18/2011 Notice of Proposed Rule]",Supporting & Related Material,BKG-Background Material,2011-05-18T04:00:00Z,2011,5,,,2011-05-18T16:06:05Z,,0,0,0900006480d4366e FDA-2011-N-0103-0002,FDA,FDA-2011-N-0103,List of References,Supporting & Related Material,BKG-Background Material,2011-05-18T04:00:00Z,2011,5,,,2016-01-12T16:29:28Z,,0,0,0900006480d43669 FDA-2011-N-0103-0005,FDA,FDA-2011-N-0103,"Reference 3 - Brown, Eric R. and William B. Cherry, ""Specific identification ofBacillus anthracis by means of a variant bacteriophage,"" vol. 96, Journal of Infectious Disease, p. 34, 2001 [5/18/2011 Notice of Proposed Rule]",Supporting & Related Material,BKG-Background Material,2011-05-18T04:00:00Z,2011,5,,,2011-05-18T16:06:07Z,,0,0,0900006480d4366f FDA-2011-N-0103-0006,FDA,FDA-2011-N-0103,"Reference 4 - Brown, Eric R. et aI., ""Differential diagnosis of Bacillus cereus, Bacillus anthracis and Bacillus cereus var. ,nycoides,"" vol. 75, Journal of Bacteriology, p. 499, 1957 [5/18/2011 Notice of Proposed Rule]",Supporting & Related Material,BKG-Background Material,2011-05-18T04:00:00Z,2011,5,,,2011-05-18T16:06:09Z,,0,0,0900006480d43a26 FDA-2011-N-0103-0001,FDA,FDA-2011-N-0103,Microbiology Devices: Classification of In Vitro Diagnostic Device for Bacillus Species Detection,Proposed Rule,NPR-Notice of Proposed Rule-Making,2011-05-18T04:00:00Z,2011,5,2011-05-18T04:00:00Z,2011-08-17T03:59:59Z,2011-05-18T13:52:27Z,2011-12088,0,0,0900006480d4154e FDA-2011-N-0103-0003,FDA,FDA-2011-N-0103,"Reference 1 -Transcript of the FDA Microbiology Devices Panel meeting, March 7. 2002, at: http://www.accessdata.fda.gov/scripts/cdrhlcfdocs/cfAdvisory/details.cfm?mtg=348 [5/18/2011 Notice of Proposed Rule]",Supporting & Related Material,BKG-Background Material,2011-05-18T04:00:00Z,2011,5,,,2011-05-18T16:06:03Z,,0,0,0900006480d4366b