PMA P110029S027
- Device
- ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S027
- Product code
- LOM
- Decision date
- 2018-07-18
- 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
- Change a quality control standard and specifications used to qualify kit subcomponents.
Current openFDA PMA Record#
- Device
- ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S027
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-07-18
- Decision code
- OK30
- Date received
- 2018-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change a quality control standard and specifications used to qualify kit subcomponents.