FDA.reportPublic FDA data

PMA P100001S014

Device
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics
PMA number
P100001
Supplement
S014
Product code
LOM
Decision date
2018-07-02
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 contract 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 5600 Immunodiagnostic System.

Current openFDA PMA Record#

Device
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics
PMA number
P100001
Supplement
S014
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2018-07-02
Decision code
APPR
Date received
2018-02-21
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for an additional contract 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 5600 Immunodiagnostic System.