AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
FDA premarket approval P050049 · decided 2006-06-01
Approval details
- PMA number
- P050049
- Trade name
- AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2005-12-06
- Decision date
- 2006-06-01
- Days to decision
- 177 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM HBSAG ASSAY, WHICH IS INDICATED FOR: AXSYM HBSAG: AXSYM HBSAG IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN NEONATAL SERUM, AND ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN POTASSIUM EDTA, SODIUM CITRATE, SODIUM HEPARIN, LITHIUM HEPARIN, OR PLASMA SEPARATOR TUBES). THE ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF ACUTE OR CHRONIC H
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358) | Abbott Laboratories, Inc. | 2009-08-06 |
| CREATININE (K061193) | Abbott Laboratories, Inc. | 2006-06-23 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| FOX PLUS PTA CATHETER (K040954) | Abbott Laboratories, Inc. | 2004-05-11 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT (K023062) | Abbott Laboratories, Inc. | 2002-09-30 |