ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
FDA premarket approval P030040 · decided 2004-08-06
Approval details
- PMA number
- P030040
- Trade name
- ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-09-11
- Decision date
- 2004-08-06
- Days to decision
- 330 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADVIA CENTAUR HBC IGM. HBC IGM READY PACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HBC IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION IF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM AND PLASMA (EDTA OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY USES RECOMBINANT HBC ANTIGEN. THIS ASSAY MAY BE USED IN COMBINATION WITH OTHER HEPATITIS B VIRUS (HBV) MARKET ASSAYS TO DEFINE THE CLIN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.