ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
FDA premarket approval P210019 · decided 2022-07-27
Approval details
- PMA number
- P210019
- Trade name
- ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2021-05-11
- Decision date
- 2022-07-27
- Days to decision
- 442 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the ADVIA Centaur® HBc Total 2 (HBcT2) assay. The ADVIA Centaur HBc Total 2 (HBcT2) assay is an in vitro diagnostic immunoassay for use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Approval for the ADVIA Centaur XP and ADVIA Centaur XPT systems.This assay can be used as an aid in the diagnosis of adults with acute or chronic hepatitis B vir
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