PMA P110029S024
- Device
- ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S024
- Product code
- LOM
- Decision date
- 2016-11-10
- 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
- Increase the batch range and modify the pooling allowances for the bulks and concentrates for components used in the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Reagents.
Current openFDA PMA Record#
- Device
- ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY,
- Applicant
- Abbott Laboratories
- PMA number
- P110029
- Supplement
- S024
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2016-11-10
- Decision code
- OK30
- Date received
- 2016-10-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase the batch range and modify the pooling allowances for the bulks and concentrates for components used in the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Reagents.