BIOTRIN PARVOVIRUS B19 IGG
FDA premarket approval P970054 · decided 1999-08-06
Approval details
- PMA number
- P970054
- Trade name
- BIOTRIN PARVOVIRUS B19 IGG
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Applicant
- Diasorin
- Date received
- 1997-08-28
- Decision date
- 1999-08-06
- Days to decision
- 708 days
- Decision code
- APPR
- Product code
- MYL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- 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
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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 |