PMA P990038S011
- Device
- ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S011
- Product code
- LOM
- Decision date
- 2006-04-19
- 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 MANUFACTURING CHANGES IN THE WAY THE POSITIVE CONTROL IS MADE.
Current openFDA PMA Record#
- Device
- ETI-MAK-2 PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S011
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2006-04-19
- Decision code
- APPR
- Date received
- 2006-03-24
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR MANUFACTURING CHANGES IN THE WAY THE POSITIVE CONTROL IS MADE.