FDA regulation of clinical microbiology diagnostic devices

Journal of Clinical Microbiology

Volumn 49, Issue 9 SUPPL., 2011, Pages

  Shawar, Ribhi ^a   Weissfeld, Alice S ^b  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^b Microbiology Specialists Incorporated   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; CONFERENCE PAPER; DEVICE; DEVICE RECALL; DEVICE SAFETY; DIAGNOSTIC DEVICE; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HUMAN; LABORATORY TEST; MARKETING; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIORITY JOURNAL;

EID: 80053187264     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.00821-11     Document Type: Conference Paper

References (16)

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