FDA.reportPublic FDA data

PMA P030026S035

Device
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P030026
Supplement
S035
Product code
LOM
Decision date
2018-12-17
Classification
Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Approval for an additional manufacturing site located at NPA de México S.A. de C.V. dba Nypro, at Sor Juana Ines de la Cruz #20150, Parque Industrial Chilpancingo, 22509 Tijuana, Baja California, Mexico, limited to manufacturing of the Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System.

Current openFDA PMA Record#

Device
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P030026
Supplement
S035
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2018-12-17
Decision code
APPR
Date received
2018-10-16
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for an additional manufacturing site located at NPA de México S.A. de C.V. dba Nypro, at Sor Juana Ines de la Cruz #20150, Parque Industrial Chilpancingo, 22509 Tijuana, Baja California, Mexico, limited to manufacturing of the Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System.