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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 134 Results
Applicant Ortho-Clinical Diagnostics, Inc. productcode LOM Decision Date To 04/25/2024
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VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S016 12/17/2018
VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S032 07/02/2018
VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S033 07/02/2018
VITROS Immunodiagnostic Products HBsAg Reagent Pac... Ortho-Clinical Diagnostics, In P000044 S037 07/02/2018
VITROS Immunodiagnostic Products HBsAg Reagent Pac... Ortho-Clinical Diagnostics, In P000044 S038 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S032 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S034 07/02/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S013 07/02/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S015 07/02/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S033 02/23/2018
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