BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
FDA premarket approval P970055/S011 · decided 2011-08-03
Approval details
- PMA number
- P970055
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Applicant
- Diasorin
- Date received
- 2011-07-06
- Decision date
- 2011-08-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MYM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- MANUFACTURING PROCESS CHANGE FOR PREPARATION OF THE SENSITIVITY STANDARDS, USED AS A REFERENCE MATERIAL TO ESTABLISH THE CUT-OFF VALUE FOR THE DEVICE.
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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 |