PMA P030026S008
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P030026
- Supplement
- S008
- Product code
- LOM
- Decision date
- 2005-10-21
- 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 THAT ADDRESSES THE ADDITION OF A CAUTION STATEMENT IN THE VITROS ANTI-HBC IGM REAGENT PACK INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P030026
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2005-10-21
- Decision code
- APPR
- Date received
- 2005-09-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE CHANGE THAT ADDRESSES THE ADDITION OF A CAUTION STATEMENT IN THE VITROS ANTI-HBC IGM REAGENT PACK INSTRUCTIONS FOR USE.