PMA P090028S010
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P090028
- Supplement
- S010
- Product code
- LOM
- Decision date
- 2017-09-12
- 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 the migration of the VITROS Immunodiagnostic Products HBeAg Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P090028
- Supplement
- S010
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-09-12
- Decision code
- APPR
- Date received
- 2016-12-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the VITROS Immunodiagnostic Products HBeAg Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.