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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceAXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
ABBOTT LABORATORIES INC
100 abbott park road
dept: 09vb bldg: ap5-2
abbott park, IL 60064
PMA NumberP060009
Date Received03/10/2006
Decision Date08/25/2006
Withdrawal Date 11/15/2013
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0160
Notice Date 04/30/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the abbott axsym core-m 2. 0 and axsym core-m 2. 0 controls. These devices are indicated for: theaxsym 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 
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