PMA P990045S014
- Device
- ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S014
- Product code
- LOM
- Decision date
- 2012-11-30
- 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 TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
Current openFDA PMA Record#
- Device
- ETI-AB-COREK PLUS ASSAY
- Applicant
- DiaSorin, Inc.
- PMA number
- P990045
- Supplement
- S014
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2012-11-30
- Decision code
- APPR
- Date received
- 2012-11-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.