Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Roche Diagnostics Corp. (PMA P100031)
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Roche Diagnostics Corp. (PMA P100031) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Applicant: Roche Diagnostics Corp.; Clearance track: PMA.
| Device name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
|---|---|
| Applicant | Roche Diagnostics Corp. |
| Clearance track | PMA |
| Submission number | P100031 |
| Decision | OK30 |
| Decision date | 2023-10-31 |
| Date received | 2023-09-21 |
| Product code | LOM |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | IN |
| Source | openFDA device |
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$1999/mo
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