PMA P000044S035
- Device
- VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P000044
- Supplement
- S035
- Product code
- LOM
- Decision date
- 2017-06-27
- 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
- Change in the process for negative plasma.
Current openFDA PMA Record#
- Device
- VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P000044
- Supplement
- S035
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-06-27
- Decision code
- OK30
- Date received
- 2017-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the process for negative plasma.