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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 HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S018 01/24/2023
VITROS HBeAg Ortho-Clinical Diagnostics, In P090028 S017 06/19/2019
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S016 12/17/2018
VITROS Immunodiagnostic Products HBeAg Reagent Pac... Ortho-Clinical Diagnostics, In P090028 S015 07/02/2018
HBeAg Reagent Pack and Calibrator Ortho-Clinical Diagnostics, In P090028 S014 02/16/2018
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 S011 10/26/2017
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PAC... Ortho-Clinical Diagnostics, In P090028 S010 09/12/2017
VITROS HBEAG ASSAY Ortho-Clinical Diagnostics, In P090028 S009 09/08/2015
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PA... Ortho-Clinical Diagnostics, In P090028 S008 07/23/2015
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