- Device
- Abbott ARCHITECT AUSAB Reagent (100 Test), Abbott ARCHITECT AUSAB Reagent (500 Test), Abbott ARCHITECT AUSAB Reagent, Al
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S042
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-09-09
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of shelf life for two in-process materials.