PMA P990045S005
- Device
- DIASORIN ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S005
- Product code
- LOM
- Decision date
- 2003-11-26
- 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 EXTENSION OF THE ETI-AB-COREK PLUS ASSAY EXPIRATION DATING FROM 7 MONTHS AND A MINOR LABELING CHANGE IN THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT TO CORRECT A CALCULATION ERROR.
Current openFDA PMA Record#
- Device
- DIASORIN ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S005
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2003-11-26
- Decision code
- APPR
- Date received
- 2003-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENSION OF THE ETI-AB-COREK PLUS ASSAY EXPIRATION DATING FROM 7 MONTHS AND A MINOR LABELING CHANGE IN THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT TO CORRECT A CALCULATION ERROR.