Elecsys HBsAg Confirmatory Test
FDA premarket approval P160019/S012 · decided 2021-12-09
Approval details
- PMA number
- P160019
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Elecsys HBsAg Confirmatory Test
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2021-08-02
- Decision date
- 2021-12-09
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval to change the serum source for the control and confirmatory reagents from human to sheep for the Elecsys HBsAg Confirmatory Test.
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