| 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 B19 IGG |
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| Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
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| Applicant | DIASORIN
1951 NORTHWESTERN AVENUE
STILLWATER, MN 55082-0285 |
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| PMA Number | P970054 |
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| Date Received | 08/28/1997 |
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| Decision Date | 08/06/1999 |
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| Product Code |
MYL |
| Docket Number | 00M-1216 |
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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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| Recalls | CDRH Recalls |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012
S013 S015 S018 S019 S020 |
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