PMA P090028S011
- Device
- VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P090028
- Supplement
- S011
- Product code
- LOM
- Decision date
- 2017-10-26
- 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
- Current Size Exclusion Chromatography component purification system be replaced with a Tangential Flow Purification System.
Current openFDA PMA Record#
- Device
- VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P090028
- Supplement
- S011
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-10-26
- Decision code
- OK30
- Date received
- 2017-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Current Size Exclusion Chromatography component purification system be replaced with a Tangential Flow Purification System.