Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
FDA premarket approval P160019 · decided 2016-12-23
Approval details
- PMA number
- P160019
- Trade name
- Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2016-07-01
- Decision date
- 2016-12-23
- Days to decision
- 175 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for the Elecsys Hbsag II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II. This device is indicated for:Elecsys HBsAg II Immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years of age) serum and plasma (sodium heparin, lithium heparin, K2 EDTA, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals at ri
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