ADVIA Centaur HBsAg
FDA premarket approval P030049/S013 · decided 2019-10-25
Approval details
- PMA number
- P030049
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA Centaur HBsAg
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2019-09-27
- Decision date
- 2019-10-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Implement two additional tiers of standards identical to the approved standard used in manufacturing.
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