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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 IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PA... Ortho-Clinical Diagnostics, In P000044 S026 05/11/2011
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PAC... Ortho-Clinical Diagnostics, In P090028 05/11/2011
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S021 04/22/2011
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S023 03/10/2011
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S022 11/16/2010
VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALI... Ortho-Clinical Diagnostics, In P000044 S025 11/16/2010
VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGE... Ortho-Clinical Diagnostics, In P030026 S020 11/16/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S024 08/30/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S021 08/19/2010
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITA... Ortho-Clinical Diagnostics, In P000014 S020 07/16/2010
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