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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 64 Results
Analyte Helicobacter pylori Complexity waived Effective Date To 11/26/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Germaine Laboratories AimStep H. pylori  {Whole Blood} 
CR140340 K980798 Helicobacter pylori antibodies General Immunology 10/06/2014
Polymedco Poly stat H. pylori  {Whole Blood} 
CR140223 K980798 Helicobacter pylori antibodies General Immunology 07/17/2014
JANT Accutest Rapid Urease test  {H. pylori detection} 
K052708   Helicobacter pylori Bacteriology 02/18/2014
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
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
Princeton BioMeditech BioSign H. pylori WB  {OSOM H. pylori} (for whole blood)
K980798   Helicobacter pylori antibodies General Immunology 11/09/2009

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