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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS ASSAYS
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametotal antibodies against hepatitis b core antigen (anti-hbc) hepatitis b surface antigen (hbsag) total antibodies againa
ApplicantDIAGNOSTIC PRODUCTS CORP.
PMA NumberP010052
Supplement NumberS004
Date Received02/25/2008
Decision Date12/16/2009
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for immulite/ immulite 1000 and immulite 2000 anti hbs assay. The device is indicated for: immulite/ immulite 1000 for in vitro diagnostic use with the immulite or immulite 1000 analyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis b surface antigen (anti-hbs) in human serum and plasma (heparinized). Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Immulite 2000 for in vitro diagnostic use with the immulite 2000 systems automated immunoassay analyzers for the qualitative and quantitative measurement of total antibodies to the hepatitis b surface antigen (anti-hbs) in human serum and plasma (heparinized). Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following i-ibv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
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