PMA P030024S017
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S017
- Product code
- LOM
- Decision date
- 2011-11-10
- 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
- APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S017
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-11-10
- Decision code
- APPR
- Date received
- 2011-10-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE CHANGE IN ON-INSTRUMENT STORAGE OF PATIENT SAMPLES FROM 2 HOURS TO 3 HOURS.