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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 Decision Date To 04/25/2024
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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S030 07/23/2015
VITROS ANTI-HBS ASSAY Ortho-Clinical Diagnostics, In P000014 S031 09/08/2015
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 Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S034 12/17/2018
VITROS Anti-HBs Ortho-Clinical Diagnostics, In P000014 S035 06/19/2019
VITROS Immunodiagnostic Products Anti-HBs Quantita... Ortho-Clinical Diagnostics, In P000014 S036 10/22/2020
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 04/27/2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBS AG REAGENT PA... Ortho-Clinical Diagnostics, In P000044 S001 05/24/2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGEN... Ortho-Clinical Diagnostics, In P000044 S002 06/18/2001
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