American ‘association of Bioanalysts
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چکیده
The American Association of Bioanalysts (AAB) a national professional association whose members are directors, owners, managers, and supervisors of community clinical laboratories respectfully submits the following comments relating to the Food and Drug Administration’s (FDA) medical devices draft guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) criteria for waiver. AAB members serve communities throughout the nation and provide integral laboratory services that assist in the diagnosis, treatment, and management of disease.
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Proficiency Testing Service American Association of Bioanalysts
Specimen 1 Organisms Referees Frequency Ext 1 Ext 2 571 Ascaris lumbricoides 18 Moderate to Many 15 49 545 Entamoeba coli 10 Moderate to Many 4 16 589 Schistosoma mansoni 6 Few to moderate 3 11 524 Parasite(s) found referred for ID 10 580 Trichuris trichiura 3 Few to moderate 6 544 Endolimax nana 2 2 574 Hookworm 1 546 Entamoeba hartmanni 1 548 Entamoeba histolytica / Entamoeba dispar 1 566 Hym...
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