PMA P100001S010
- Device
- VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- 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 Anti-HBe 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 ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- 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
- 2016-11-17
- 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 Anti-HBe Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.