ADVIA CENTAUR HBSAG (HBS) ASSAY
FDA premarket approval P030049/S011 · decided 2014-10-28
Approval details
- PMA number
- P030049
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR HBSAG (HBS) ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2014-07-10
- Decision date
- 2014-10-28
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADDITION OF TWO WASHES OF THE ANCILLARY PROBE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP INSTRUMENTS WHEN THE ADVIA CENTAUR HBSAG ASSAY IS RUN IMMEDIATELY FOLLOWING THE ADVIA CENTAUR SYPHILIS ASSAY.
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