| 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 | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus |
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| Generic Name | ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG |
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| Applicant | DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082 |
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| PMA Number | P220034 |
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| Date Received | 12/27/2022 |
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| Decision Date | 03/29/2024 |
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| Product Code |
MYL |
| Docket Number | 24M-1612 |
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| Notice Date | 04/05/2024 |
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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
Approval for LIAISON Biotrin Parvovirus B19 IgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus. The LIAISON Biotrin Parvovirus B19 IgG Plus, a chemiluminescent immunoassay (CLIA), is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, dipotassium EDTA (K2-EDTA), and sodium citrated plasma. The test may be used for testing women of childbearing age where there is a suspicion of exposure to human B19V. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum). The test must be performed on the LIAISON XL Analyzer. |
| 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 |
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