PMA P100001S003
- Device
- VITROS ANTI-HBE
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2012-11-13
- 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
- MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.
Current openFDA PMA Record#
- Device
- VITROS ANTI-HBE
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P100001
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-11-13
- Decision code
- OK30
- Date received
- 2012-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO THE COMPONENT PARTS OF THE LUMINOMETER SIGNAL PROCESSOR BOARD (LSPB). THE LSPB IS USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.