PMA P030024
- Device
- VITROS Anti-HBc
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S029
- Product code
- LOM
- Decision date
- 2019-06-19
- 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
- Establishment of a new Environmental Controlled Area Room at an existing facility.
Current openFDA PMA Record#
- Device
- VITROS Anti-HBc
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S029
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-06-19
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Establishment of a new Environmental Controlled Area Room at an existing facility.