Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus — OraSure Technologies, Inc. (PMA P080027)
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus — OraSure Technologies, Inc. (PMA P080027) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Applicant: OraSure Technologies, Inc.; Clearance track: PMA.
| Device name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
|---|---|
| Applicant | OraSure Technologies, Inc. |
| Clearance track | PMA |
| Submission number | P080027 |
| Decision | OK30 |
| Decision date | 2015-10-15 |
| Date received | 2015-09-03 |
| Product code | MZO |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | PA |
| Source | openFDA device |
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$1999/mo
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