PMA P990042S001
- Device
- ETI-AB-AUK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2002-02-04
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR THE MODIFICATION TO THE ASSAY CUTOFF FROM 15 MIU/ML TO 10 MIU/ML.
Current openFDA PMA Record#
- Device
- ETI-AB-AUK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2002-02-04
- Decision code
- APPR
- Date received
- 2001-09-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE MODIFICATION TO THE ASSAY CUTOFF FROM 15 MIU/ML TO 10 MIU/ML.