ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
FDA premarket approval P030040/S011 · decided 2016-12-25
Approval details
- PMA number
- P030040
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2016-07-05
- Decision date
- 2016-12-25
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for a claim to test a pediatric population with the FDA approved ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur® HBc IgM Assay and is indicated for:ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systemsThe ADVIA Centaur® HBc IgM (aHBcM) assay is an in vitro diagnostic test for the qualitative determination of lgM response to hepatitis B virus core antigen
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