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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 111 Results
Analyte Fecal Occult Blood Complexity waived Effective Date To 10/24/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Rapid Response(TM) FIT - Fecal Immunochemical Test  
K110309   Fecal occult blood General Chemistry 04/22/2014
Medline Fecal Occult Blood Test  (Cassette)
K070660   Fecal occult blood General Chemistry 08/22/2013
OSOMĀ® iFOB Test OSOMĀ® iFOBT Control Kit  
K121397   Fecal occult blood General Chemistry 01/03/2013
Medline iFOB One-Step Immunological Fecal Occult Blood Test  
K100031   Fecal occult blood General Chemistry 04/19/2012
Tianjin New Bay Bioresearch Co., Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test  
K073431   Fecal occult blood General Chemistry 02/22/2012
Status iFOBT  
K100817   Fecal occult blood General Chemistry 10/19/2011
Orient Gene Biotech - One Step Rapid FOB  
K110309   Fecal occult blood General Chemistry 09/20/2011
OC-Light iFOB Test  
K041297   Fecal occult blood General Chemistry 03/24/2011
hema screen ER  
K102664   Fecal occult blood General Chemistry 02/02/2011
Siemens Hematest Reagent Tablets  (Pre-amendment device)
X100047   Fecal occult blood General Chemistry 12/17/2010

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