PMA P990041S004
- Device
- DIASORIN ETI-AB-EBK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990041
- Supplement
- S004
- Product code
- LOM
- Decision date
- 2004-02-20
- 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 FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
Current openFDA PMA Record#
- Device
- DIASORIN ETI-AB-EBK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990041
- Supplement
- S004
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2004-02-20
- Decision code
- APPR
- Date received
- 2004-01-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."