| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS |
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| Classification Name | test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | ABBOTT LABORATORIES INC |
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| PMA Number | P060009 |
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| Date Received | 03/10/2006 |
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| Decision Date | 08/25/2006 |
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| Product Code | |
| Docket Number | 07M-0160 |
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| Notice Date | 04/30/2007 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the abbott axsym core-m 2. 0 and axsym core-m 2. 0 controls. These devices are indicated for: the axsym core-m 2. 0 is a microparticle enzyme immunoassay (meia) intended for the in vitro qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti-hbc) in 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 recent hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. The axsym core-m 2. 0 controls are used for monitoring the performance of the axsym system (reagent and instrument) when used for the qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti hbc) when using the axsym core-m 2. 0 reagent pack. The performance of the axsym core-m 2. 0 controls has not been established with any other anti-hbc assays. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S007 |
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