ADVIA CENTAUR HBC IGM ASSAY
FDA premarket approval P030040/S007 · decided 2010-03-16
Approval details
- PMA number
- P030040
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR HBC IGM ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2010-02-18
- Decision date
- 2010-03-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL USED IN THE PRODUCTION OF THE ASSAY LITE REAGENT.
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