PMA P100001S001
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2012-04-16
- 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 TIMING OF THE QA RELEASE TESTS FROM SEQUENTIAL TO CONCURRENT.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-04-16
- Decision code
- OK30
- Date received
- 2012-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE TIMING OF THE QA RELEASE TESTS FROM SEQUENTIAL TO CONCURRENT.