AXSYM, AUSAB
FDA premarket approval P060003 · decided 2006-08-07
Approval details
- PMA number
- P060003
- Trade name
- AXSYM, AUSAB
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2006-02-10
- Decision date
- 2006-08-07
- Days to decision
- 178 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE AXSYM AUSAB ASSAY. THE DEVICE IS INDICATED FOR: AXSYM AUSAB REAGENT PACK IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN SODIUM HEPARIN). THE ASSAY IS USED FOR THE QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE TO HEPATITIS B VIRUS (HBV) VACCINATION FOR THE DETERMINATION OF HBV IMMU
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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 |