CLIA - Clinical Laboratory Improvement Amendments

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Analyte Helicobacter Pylori Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Accutest H. pylori Rapid Test-Serum (Dip Strip) {Jant Pharmacal}
K024360	Helicobacter Pylori	Bacteriology	10/04/2010
ARJ Pylo-Plus Urease Test {H. pylori detection}
K052708	Helicobacter Pylori	Bacteriology	01/20/2010
EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST
K024360	Helicobacter Pylori	Bacteriology	05/21/2009
Meridian Bioscience Immunocard STAT! HpSA (Stool)
K032222	Helicobacter Pylori	Bacteriology	05/31/2006
Acon Helicobacter Pylori Rapid Test Device
K024350	Helicobacter Pylori	Bacteriology	03/23/2004
GI SUPPLY, DIV. CHEK-MED SYSTEMS HP ONE
K012411	Helicobacter Pylori	Bacteriology	03/24/2003
SERIM PYLORITEK VP TEST KIT
K014038	Helicobacter Pylori	Bacteriology	07/25/2002
MEDICAL INSTRUMENTS PRONTO DRY
K002451	Helicobacter Pylori	Bacteriology	08/30/2001
Ballard Medical Products CLOtest
	Helicobacter Pylori	Bacteriology	10/05/1999
GI Supply HP-FAST
K944903	Helicobacter Pylori	Bacteriology	03/28/1997