Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
FDA premarket approval P100039/S005 · decided 2018-05-23
Approval details
- PMA number
- P100039
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2017-07-14
- Decision date
- 2018-05-23
- Days to decision
- 313 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Aproval for the migration of the ADVIA Centaur Anti-HBs2 (aHBs2) assay to the Atellica IM Analyzer.
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