Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay
FDA premarket approval P100039/S009 · decided 2020-04-03
Approval details
- PMA number
- P100039
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2020-03-09
- Decision date
- 2020-04-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).
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