Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
FDA premarket approval P190034 · decided 2021-02-23
Approval details
- PMA number
- P190034
- Trade name
- Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Roche Diagnostics
- Date received
- 2019-12-30
- Decision date
- 2021-02-23
- Days to decision
- 421 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck.Elecsys Anti-HBs II Immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human adult, pregnant women, and pediatric (ages 2 to 21 years) serum and plasma (K2-EDTA and K3-EDTA). Assay results may be used as an aid in the determination of susceptibilty to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination; or where
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