- Device
- EBK RIA ASSAY/ETI-EBK
- Applicant
- Diasorin
- PMA number
- P870048
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2001-02-02
- Decision code
- APPR
- Date received
- 2000-10-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE NEGATIVE AND POSITIVE CONTROLS AND THE NEUTRALIZING SOLUTIONS FROM DEFIBRINATED PLASMA TO SERUM AND A CHANGE IN THE PURIFICATION PROCESS AND SHELF LIFE OF SOME COMPONENTS OF THE EBK DEVICE AND THE ETI-EBK DEVICE.