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PMA P010021S030

Device
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P010021
Supplement
S030
Product code
MZO
Decision date
2018-07-02
Classification
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
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-HCV Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P010021
Supplement
S030
Product code
MZO
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
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.