PMA P990042S015

Device: ETI-AB-AUK PLUS ASSAY
Applicant: DiaSorin, Inc.
PMA number: P990042
Supplement: S015
Product code: LOM
Decision date: 2014-01-10
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-AB-AUK PLUS ASSAY
Applicant: DiaSorin, Inc.
PMA number: P990042
Supplement: S015
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.