PMA P100001S008
- Device
- VITROS ANTI-HBE ASSAY
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S008
- Product code
- LOM
- Decision date
- 2015-09-08
- 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 TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
Current openFDA PMA Record#
- Device
- VITROS ANTI-HBE ASSAY
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2015-09-08
- Decision code
- OK30
- Date received
- 2015-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.