PMA P030024S024
- Device
- VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S024
- Product code
- LOM
- Decision date
- 2017-09-01
- 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
- Process improvements to increase to maximum batch size for manufacturing of anti-HBc coated wells from 2500 to 5000 plates.
Current openFDA PMA Record#
- Device
- VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S024
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-09-01
- Decision code
- OK30
- Date received
- 2017-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process improvements to increase to maximum batch size for manufacturing of anti-HBc coated wells from 2500 to 5000 plates.