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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 HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S015 03/27/2007
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S012 03/05/2007
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HBC IGM REAGE... Ortho-Clinical Diagnostics, In P030026 S011 09/12/2006
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S014 09/06/2006
VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRA... Ortho-Clinical Diagnostics, In P000044 S013 07/14/2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT ... Ortho-Clinical Diagnostics, In P000014 S014 06/05/2006
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S012 06/05/2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAG... Ortho-Clinical Diagnostics, In P030026 S010 06/05/2006
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PAC... Ortho-Clinical Diagnostics, In P000044 S011 04/03/2006
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AN... Ortho-Clinical Diagnostics, In P000014 S013 12/08/2005
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