ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
FDA premarket approval P030029 · decided 2004-05-14
Approval details
- PMA number
- P030029
- Trade name
- ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-07-02
- Decision date
- 2004-05-14
- Days to decision
- 317 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND ADVIA CENTAUR ANTI-HBS READYPACK CALIBRATORS. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM OR PLASMA (EDTA OR HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNK
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