Atellica IM Hepatitis B e Antigen (HBeAg)
FDA premarket approval P090024/S004 · decided 2018-07-12
Approval details
- PMA number
- P090024
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Atellica IM Hepatitis B e Antigen (HBeAg)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2017-12-22
- Decision date
- 2018-07-12
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for migration of the ADVIA Centaur Hepatitis B e Antigen and the ADVIA Centaur Hepatitis B e Antigen Quality Control onto the Atellica IM analyzer. The device, as modified, will be marketed under the trade name Atellica IM Hepatitis B e Antigen (HBeAg) and Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC) and is indicated for: Atellica IM Hepatitis Be Antigen (HBeAg)The Atellica IM Hepatitis Be Antigen (HBeAg) assay is an in vitro diagnostic immunoassay for use in the qualita
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