ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials
FDA premarket approval P040004/S018 · decided 2020-08-25
Approval details
- PMA number
- P040004
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2020-07-31
- Decision date
- 2020-08-25
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Procedure for testing raw materials, in-process and final products.
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