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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 IGM REAGENT PAK/CALIBRATOR
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameanti-hbc igm assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP030026
Date Received06/27/2003
Decision Date03/04/2004
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 04M-0356
Notice Date 08/09/2004
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 igm reagent pack and vitros immunodiagnostic products anti-hbc igm calibrator. These devices are indicated for: 1) vitros immunodiagnostic products anti-hbc igm reagent pack is indicated for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (heparin, 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. 2) vitros immunodiagnostic products anti-hbc igm calibrator is indicated for the use in the calibration of the vitros immunodiagnostic system for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (edta, heparin or citrate) and neonate serum using vitro anti-hbc igm 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 S022 S023 S024 S025 S026 S027 
S028 
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