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Tests / Presumptive and confirmatory tests / HIV test / Medical laboratory / Quality assurance / Point-of-care testing / Acceptance testing / Sunquest Information Systems / Medicine / Health / Science


Microsoft Word - Guidance FAQ document 11_01_13_revised.doc
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Document Date: 2013-11-08 11:31:57

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File Size: 40,50 KB

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City

New York City / /

Company

New York State / Limited Service Laboratories / /

Event

Product Recall / Product Issues / /

Facility

Laboratory Medicine / /

IndustryTerm

test device / electronic systems / treatment of any disease / /

MedicalCondition

HIV / communicable diseases / disease / /

MedicalTreatment

surgery / osteopathy / /

Organization

Dept of Health / Food and Drug Administration / Department of Health / /

Position

physician / director at laboratories conducting waived testing only / laboratory director at laboratories performing waived or PPMP testing / General / director of the permitted laboratory / director of a limited services laboratory / director for the limited services laboratory / laboratory director / co-worker / Supervisor /director watching staff collect / outside consultant / nurse / /

Product

devices / /

URL

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/analytesw / www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/testswaive / www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/ppmplist.pdf / www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm / /

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