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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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31 to 40 of 134 Results
Applicant Ortho-Clinical Diagnostics, Inc. productcode LOM Decision Date To 04/25/2024
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VITROS HBSAG ASSAY Ortho-Clinical Diagnostics, In P000044 S032 09/08/2015
VITROS ANTI-HBC IGM ASSAY Ortho-Clinical Diagnostics, In P030026 S030 09/08/2015
VITROS HBEAG ASSAY Ortho-Clinical Diagnostics, In P090028 S009 09/08/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S030 07/23/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S031 07/23/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PA... Ortho-Clinical Diagnostics, In P090028 S008 07/23/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S029 02/12/2015
VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAG... Ortho-Clinical Diagnostics, In P000014 S028 12/11/2014
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, In P000014 S027 03/10/2014
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S028 10/17/2013
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