PMA P990044S016
- Device
- ETI-CORE-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S016
- Product code
- LOM
- Decision date
- 2014-01-10
- 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
- MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
Current openFDA PMA Record#
- Device
- ETI-CORE-IGMK PLUS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S016
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2014-01-10
- Decision code
- OK30
- Date received
- 2013-12-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.