ADVIA CENTAUR AHBS ASSAY
FDA premarket approval P030029/S008 · decided 2009-09-15
Approval details
- PMA number
- P030029
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR AHBS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-08-21
- Decision date
- 2009-09-15
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- CHANGE FROM 20 GRAMS TO 60 GRAMS FOR THE ANTI-HBS WETCAKE USED IN THE PRODUCTION OF AHBS REAGENT.
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