VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
FDA premarket approval P000044/S037 · decided 2018-07-02
Approval details
- PMA number
- P000044
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2018-01-09
- Decision date
- 2018-07-02
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- 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 3600 Immunodiagnostic System.
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