| 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. |
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| Device | BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) |
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| Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM |
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| Applicant | DIASORIN
1951 NORTHWESTERN AVENUE
STILLWATER, MN 55082-0285 |
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| PMA Number | P970055 |
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| Date Received | 08/28/1997 |
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| Decision Date | 08/06/1999 |
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| Product Code |
MYM |
| Docket Number | 00M-1215 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S010 S012 S004 S005 S006 S014 S011 S013 S001 S008 S002
S007 S009 S015 S019 S017 S020 S021 S022 |
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