Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
FDA premarket approval P100039/S006 · decided 2018-09-11
Approval details
- PMA number
- P100039
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2018-07-19
- Decision date
- 2018-09-11
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the placement of these assays on the Atellica Solution.
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