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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.
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970055
Date Received08/28/1997
Decision Date08/06/1999
Product Code
MYM[ Registered Establishments with MYM ]
Docket Number 00M-1215
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device is intended for the qualitative detection if IgM antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human seru, lithium heparin, EDTA, and citrated plasma. This test, in conjunction with the Biotrin Parvovirus B19 IgG 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 to make 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 S014 S015