| 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. |
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| Trade Name | BIOTRIN PARVOVIRUS B19 IGG |
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| Classification Name | assay,enzyme linked immunosorbent,parvovirus b19 igg |
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| Generic Name | biotrin parvovirus b19 igg |
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| Applicant | DIASORIN |
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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 | |
| 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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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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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| Supplements: |
S001 S002 S004 S005 S006 S007
S008 S009 |
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