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withdrawn,object_id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-2009-D-0137-0028,FDA,FDA-2009-D-0137,"Amendment to Guidance for Industry: Use of Serological Tests To Reduce
the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability",Notice,Notice of Availability,2016-11-10T05:00:00Z,2016,11,2016-11-10T05:00:00Z,2017-02-09T04:59:59Z,2017-02-07T02:02:05Z,2016-27107,0,0,0900006482387508
FDA-2009-D-0137-0036,FDA,FDA-2009-D-0137,"Reference 7 Donors deferred for self-reported Chagas disease history:
does it reduce risk?",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:11Z,,0,0,09000064823877ec
FDA-2009-D-0137-0031,FDA,FDA-2009-D-0137,"Reference 2-Autochthonous Transmission of Trypanosoma cruzi, Louisiana",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:56Z,,0,0,0900006482387a72
FDA-2009-D-0137-0038,FDA,FDA-2009-D-0137,Reference 9 Trypanosoma cruzi (E. coli Recombinant) Antigen ABBOTT PRISM Chagas Package Insert (2010),Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:17Z,,0,0,09000064823877ee
FDA-2009-D-0137-0029,FDA,FDA-2009-D-0137,Amendment to “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion”,Other,Guidance,2016-11-10T05:00:00Z,2016,11,2016-11-10T05:00:00Z,2017-02-09T04:59:59Z,2024-11-12T06:15:55Z,,1,0,0900006482387a6f
FDA-2009-D-0137-0039,FDA,FDA-2009-D-0137,Reference 10  FDA Blood Products Advisory Committee T. cruzi Incidence Study in Blood Donors and its Implications for One-time Testing of Blood Donors August 2 2011,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:20Z,,0,0,09000064823877ef
FDA-2009-D-0137-0042,FDA,FDA-2009-D-0137,Reference 13 Trypanosoma cruzi (E coli) Recombinant Antigen ABBOTT ESA Chagas Package Insert 2011,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:29Z,,0,0,09000064823877f2
FDA-2009-D-0137-0035,FDA,FDA-2009-D-0137,Reference 6-Epidemiology of American Trypanosomiasis (Chagas Disease),Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:08Z,,0,0,09000064823877eb
FDA-2009-D-0137-0037,FDA,FDA-2009-D-0137,Reference 8 Trypanosoma cruzi (T cruzi) Whole Cell Lysate Antigen ORTHO T cruzi ELISA Test System Package Insert 2009,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:15Z,,0,0,09000064823877ed
FDA-2009-D-0137-0032,FDA,FDA-2009-D-0137,Reference 3-Case Report: Evidence of Autochthonous Chagas Disease in Southeastern Texas,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:58Z,,0,0,0900006482387a73
FDA-2009-D-0137-0033,FDA,FDA-2009-D-0137,Reference 4-An Estimate of the Burden of Chagas Disease in the United States,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:02Z,,0,0,0900006482387a74
FDA-2009-D-0137-0034,FDA,FDA-2009-D-0137,"Reference 5-Trypanosoma cruzi infection in North America and Spain:
evidence in support of transfusion transmission",Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:05Z,,0,0,09000064823877ea
FDA-2009-D-0137-0040,FDA,FDA-2009-D-0137,Reference 11 FDA Blood Products Advisory Committee Reentry of blood donors deferred on the basis of screening test results for antibodies to T. cruzi July 31 2014,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:23Z,,0,0,09000064823877f0
FDA-2009-D-0137-0030,FDA,FDA-2009-D-0137,AMENDMENT TO “GUIDANCE FOR INDUSTRY: USE OF SEROLOGICAL TESTS TO REDUCE THE RISK OF TRANSMISSION OF TRYPANOSOMA CRUZI INFECTION IN WHOLE BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION” DRAFT GUIDANCE FOR INDUSTRY,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:30:52Z,,0,0,0900006482387a71
FDA-2009-D-0137-0041,FDA,FDA-2009-D-0137,Reference 12 FDA Blood Products Advisory Committee Potential Testing Strategies for T. cruzi Infection in Blood Donors April 1 2009,Supporting & Related Material,Background Material,2016-11-10T05:00:00Z,2016,11,,,2016-11-10T15:31:26Z,,0,0,09000064823877f1