Atellica IM Hepatitis B core IgM (aHBcM)
FDA premarket approval P030040/S023 · decided 2024-12-17
Approval details
- PMA number
- P030040
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Atellica IM Hepatitis B core IgM (aHBcM)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2024-06-13
- Decision date
- 2024-12-17
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur HBc IgM (aHBcM) assay (P030040), from the ADVIA Centaur XP to the Atellica CI analyzer, which will be known as the Atellica IM Hepatitis B core IgM (aHBcM) assay.
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