FDA.reportPublic FDA data

PMA P050051S040

Device
ARCHITECT AUSAB and Alinity i Anti-HBs
Applicant
Abbott Laboratories, Inc.
PMA number
P050051
Supplement
S040
Product code
LOM
Decision date
2020-11-05
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.

Current openFDA PMA Record#

Device
ARCHITECT AUSAB and Alinity i Anti-HBs
Applicant
Abbott Laboratories, Inc.
PMA number
P050051
Supplement
S040
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2020-11-05
Decision code
OK30
Date received
2020-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.