PMA P030024S007
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S007
- Product code
- LOM
- Decision date
- 2008-02-12
- 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 ADDITION OF A NEW PROCESS STEP TO IDENTIFY AND DILUTE SAMPLES WITH HIGH RESULT SIGNAL-TO-CUTOFF RATIO (S/C) ABOVE THE NORMAL NEGATIVE POPULATION AND THE CHANGES INVOLVED IN ADDING THIS NEW PROCESS. THESE CHANGES ARE AN UPDATE TO THE MAGNETIC CARD AND TO THE LABELING OF THE VITROS ANTI-HBC REAGENT PACK TO SUPPORT THE IDENTIFICATION, DILUTION AND TESTING OF THE HIGH NEGATIVE SAMPLES.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S007
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2008-02-12
- Decision code
- APPR
- Date received
- 2007-12-10
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW PROCESS STEP TO IDENTIFY AND DILUTE SAMPLES WITH HIGH RESULT SIGNAL-TO-CUTOFF RATIO (S/C) ABOVE THE NORMAL NEGATIVE POPULATION AND THE CHANGES INVOLVED IN ADDING THIS NEW PROCESS. THESE CHANGES ARE AN UPDATE TO THE MAGNETIC CARD AND TO THE LABELING OF THE VITROS ANTI-HBC REAGENT PACK TO SUPPORT THE IDENTIFICATION, DILUTION AND TESTING OF THE HIGH NEGATIVE SAMPLES.