CLIA - Clinical Laboratory Improvement Amendments

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Analyte Helicobacter Pylori Antibodies Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
McKesson H. pylori Test {Whole Blood}
K024350	Helicobacter Pylori Antibodies	General Immunology	04/03/2012
PSS Consult H. pylori Cassette {Whole Blood, fingerstick only}
K024350	Helicobacter Pylori Antibodies	General Immunology	02/03/2012
LifeSign, LLC Status H. pylori {OSOM H. pylori} (for whole blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	12/06/2011
Stanbio RELY H. pylori Rapid Test (Whole Blood) {Finger-stick only}
K024350	Helicobacter Pylori Antibodies	General Immunology	04/07/2011
Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} (for whole blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	11/09/2009
Pro-Advantage by NDC H. Pylori Device {Whole Blood}
K024350	Helicobacter Pylori Antibodies	General Immunology	08/07/2009
Inverness Medical SIGNIFY H. PYLORI WHOLE BLOOD
K024350	Helicobacter Pylori Antibodies	General Immunology	05/21/2009
Cliawaived, Inc. CLIAWAIVED H. PYLORI WHOLE BLOOD RAPID TEST
K024360	Helicobacter Pylori Antibodies	General Immunology	01/22/2009
Diagnostic Test Group Clarity H. pylori Rapid Test Device (Whole Blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	01/22/2008
BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device
K024360	Helicobacter Pylori Antibodies	General Immunology	01/15/2008