Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing

Docket ID: FDA-2011-D-0272
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Status: OPEN
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): cdrh201136, Diagnostic Testing, Neisseria gonorrhoea, Chlamydia , trachomatis , In Vitro
Type: Nonrulemaking
Center: CDRH
Docket Item Code: D

Primary Documents

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Comment Period Closed
Aug 09, 2011 11:59 PM ET
Posted: 05/11/2011
ID: FDA-2011-D-0272-0001

Supporting Documents

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Comments Received*
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