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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant Ortho-Clinical Diagnostics, Inc. productcode LOM
 
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VITROS Anti-HBc IgM Ortho-Clinical Diagnostics, In P030026 S037 01/24/2023
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S018 01/24/2023
VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S036 10/22/2020
VITROS Anti-HBs Ortho-Clinical Diagnostics, In P000014 S035 06/19/2019
VITROS HBsAg Ortho-Clinical Diagnostics, In P000044 S040 06/19/2019
VITROS Anti-HBc IgM Ortho-Clinical Diagnostics, In P030026 S036 06/19/2019
VITROS HBeAg Ortho-Clinical Diagnostics, In P090028 S017 06/19/2019
VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S034 12/17/2018
VITROS Immunodiagnostic Products HBsAg Reagent Pac... Ortho-Clinical Diagnostics, In P000044 S039 12/17/2018
VITROS Immunodiagnostic Products Anti-HBc IgM Reag... Ortho-Clinical Diagnostics, In P030026 S035 12/17/2018
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