PMA P030024S026

Device

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Applicant

Ortho-Clinical Diagnostics

PMA number

P030024

Supplement

S026

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.

Summary

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