PMA P000014S029
- Device
- VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P000014
- Supplement
- S029
- Product code
- LOM
- Decision date
- 2015-12-16
- 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
- APPROVAL FOR REMOVAL OF ANTIFOAM FROM A REAGENT AND IMPLEMENTATION OF A NEW WELL WASH PROTOCOL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS.
Current openFDA PMA Record#
- Device
- VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P000014
- Supplement
- S029
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2015-12-16
- Decision code
- APPR
- Date received
- 2015-06-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REMOVAL OF ANTIFOAM FROM A REAGENT AND IMPLEMENTATION OF A NEW WELL WASH PROTOCOL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS.