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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970054
Date Received08/28/1997
Decision Date08/06/1999
Product Code
MYL[ Registered Establishments with MYL ]
Docket Number 00M-1216
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device is indicated for: The Biotrin Parvovirus B19 IgG Enzyme Immunoassay is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, EDTA, and citrated plasma. This test, in conjunction w/the Biotrin Parvovirus B19 IgM Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V. The results of these assays may be used tomake a serological determination of past, recent, or current infection with B19V. The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013