ADVIA Centaur Anti-HBe2 (aHBe2) assay
FDA premarket approval P200017 · decided 2021-07-14
Approval details
- PMA number
- P200017
- Trade name
- ADVIA Centaur Anti-HBe2 (aHBe2) assay
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2020-03-09
- Decision date
- 2021-07-14
- Days to decision
- 492 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval of the ADIVA Centaur Anti-HBe2 (aHBe2) assay. The qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (221 years old) and adult serum, EDTA plasma, or lithium heparin plasma using the ADVIA Centaur systems (XP/XPT/CP). Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with signs or symptoms of hepatitis B infection
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