PMA P990045S009
- Device
- ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S009
- Product code
- LOM
- Decision date
- 2010-01-12
- 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 A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S009
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2010-01-12
- Decision code
- APPR
- Date received
- 2009-11-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.