BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
FDA premarket approval P970055 · decided 1999-08-06
Approval details
- PMA number
- P970055
- Trade name
- BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Applicant
- Diasorin
- Date received
- 1997-08-28
- Decision date
- 1999-08-06
- Days to decision
- 708 days
- Decision code
- APPR
- Product code
- MYM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- 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, rec
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |