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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode MAQ PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
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PMA
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DIGENE HC2 SYSTEM SOFTWARE QIAGEN GAITHERSBURG, INC P890064 S031 10/09/2014
DIGENE HC2 STSTEM SOFTWARE QIAGEN GAITHERSBURG, INC P890064 S030 05/12/2014
CERVISTA HPV HR AND GENFIND KIT HOLOGIC, INC. P080014 S018 04/29/2014
CERVISTA HPV 16/18 HOLOGIC, INC. P080015 S009 04/29/2014
COBAS HPV TEST Roche Molecular Systems, Inc. P100020 S008 04/24/2014
DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 H... QIAGEN GAITHERSBURG, INC P890064 S029 04/14/2014
CERVISTA HPV HR TEST HOLOGIC, INC. P080014 S019 03/04/2014
CERVISTA HPV 16/18 TEST HOLOGIC, INC. P080015 S010 03/04/2014
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