ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
FDA premarket approval P100039/S002 · decided 2013-09-26
Approval details
- PMA number
- P100039
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2012-09-28
- Decision date
- 2013-09-26
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR THE AD VIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVEMATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AD VIA CENTAUR ANTIHBS2(AHBS2) ASSAY, ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, ANDADVIA CENTAUR ANTI-HBS2 (AHBS2) MASTER CURVE MATERIAL AND IS INDICATED FOR:ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY: THE ADVIA CENTAUR ANTI-HBS2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETENNINATION OF TOTAL ANTIBODIES TO HEPATIT
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