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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.
 
Trade NameVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameantibody to hepatitis b core antigen (anti-hbc) assay
ApplicantORTHO-CLINICAL DIAGNOSTICS
PMA NumberP030024
Date Received06/19/2003
Decision Date03/04/2004
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 04M-0341
Notice Date 08/04/2004
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vitros immunodiagnostic products anti-hbc reagent pack and vitros immunodiagnostic products anti-hbc calibrator. These devices are indicated for: 1) vitros immunodiagnostic products anti-hbc reagent pack is indicated for the in vitro qualitative detection of total antibody (igg and igm) to hepatitis b core antigen (total anti-hbc) in human adult and pediatric serum and plasma (edta and citrate) and neonate serum using the vitros eci immunodiagnostic system. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b, or recovery from hepatitis b infection. The presence of anti-hbc may be used as an aid in the determination of exposure to hbv infection for individuals prior to hbv vaccination. 2) vitros immunodiagnostic products anti-hbc calibrator is indicated for use in the calibration of the vitros eci immunodiagnostic system when used for the in vitro qualitative detection of total antibody (igg and igm) to hepatitis b core antigen (total anti-hbc) in human adult and pediatric serum and plasma (edta and citrate) and neonate serum using vitros anti-hbc reagent packs.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 
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