Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)
FDA premarket approval P970054/S015 · decided 2019-06-13
Approval details
- PMA number
- P970054
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Applicant
- Diasorin
- Date received
- 2018-08-08
- Decision date
- 2019-06-13
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- MYL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for relocating the manufacturing site to DiaSorin S.p.A., at Via Crescentino Snc, Saluggia, Italy.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |