Elecsys Anti-HBe, PreciControl Anti-HBe
FDA premarket approval P190005 · decided 2021-02-03
Approval details
- PMA number
- P190005
- Trade name
- Elecsys Anti-HBe, PreciControl Anti-HBe
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Roche Diagnostics
- Date received
- 2019-03-01
- Decision date
- 2021-02-03
- Days to decision
- 705 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the Elecsys Anti-HBe The device is an immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human adult serum or plasma (potassium EDTA, lithium heparin, sodium citrate, sodium heparin) from individuals with symptoms of hepatitis or at risk for hepatitis B virus (HBV) infection. 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)
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