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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 134 Results
Applicant Ortho-Clinical Diagnostics, Inc. productcode LOM Decision Date To 04/25/2024
 
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ANTI-HBC REAGENT PACK AND CALIBRATOR Ortho-Clinical Diagnostics, In P030026 S019 07/16/2010
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, In P000014 S027 03/10/2014
HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, In P090028 S014 02/16/2018
HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT Ortho-Clinical Diagnostics, In P000044 S023 07/16/2010
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AN... Ortho-Clinical Diagnostics, In P000014 S013 12/08/2005
VITROS ANTI-HBC IGM Ortho-Clinical Diagnostics, In P030026 S026 11/13/2012
VITROS Anti-HBc IgM Ortho-Clinical Diagnostics, In P030026 S037 01/24/2023
VITROS Anti-HBc IgM Ortho-Clinical Diagnostics, In P030026 S036 06/19/2019
VITROS ANTI-HBC IGM ASSAY Ortho-Clinical Diagnostics, In P030026 S030 09/08/2015
VITROS ANTI-HBS Ortho-Clinical Diagnostics, In P000014 S026 11/13/2012
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