Assay, Genotyping, Hepatitis C Virus — Fujirebio Europe N.V. (PMA P160016)
Assay, Genotyping, Hepatitis C Virus — Fujirebio Europe N.V. (PMA P160016) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Assay, Genotyping, Hepatitis C Virus; Applicant: Fujirebio Europe N.V.; Clearance track: PMA.
| Device name | Assay, Genotyping, Hepatitis C Virus |
|---|---|
| Applicant | Fujirebio Europe N.V. |
| Clearance track | PMA |
| Submission number | P160016 |
| Decision | OK30 |
| Decision date | 2019-09-20 |
| Date received | 2019-07-25 |
| Product code | OBF |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | US |
| Source | openFDA device |
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$1999/mo
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