FDA.reportPublic FDA data

PMA P110041S009

Device
Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co
Applicant
Siemens Corp.
PMA number
P110041
Supplement
S009
Product code
LOM
Decision date
2020-04-03
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

Current openFDA PMA Record#

Device
Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co
Applicant
Siemens Corp.
PMA number
P110041
Supplement
S009
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2020-04-03
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).