Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
FDA premarket approval P160019/S003 · decided 2018-01-18
Approval details
- PMA number
- P160019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2017-07-28
- Decision date
- 2018-01-18
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for migration of the Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II onto the cobas e 411 immunoassay analyzer.
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