PMA P030026S033
- Device
- VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P030026
- Supplement
- S033
- Product code
- LOM
- Decision date
- 2018-02-23
- 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
- Remove the requirement to functionally test an incoming raw material and release it based on supplier data in the Certificate of Analysis.
Current openFDA PMA Record#
- Device
- VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P030026
- Supplement
- S033
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-02-23
- Decision code
- OK30
- Date received
- 2018-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove the requirement to functionally test an incoming raw material and release it based on supplier data in the Certificate of Analysis.