PMA P990042S008
- Device
- ETI-MAX 3000 ANALYZER
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S008
- Product code
- LOM
- Decision date
- 2011-01-14
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR THE ETI-AB-AUK PLUS ASSAY ON THE ETI-MAX 3000 ANALYZER.
Current openFDA PMA Record#
- Device
- ETI-MAX 3000 ANALYZER
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S008
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-01-14
- Decision code
- APPR
- Date received
- 2008-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ETI-AB-AUK PLUS ASSAY ON THE ETI-MAX 3000 ANALYZER.