| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Roche Diagnostics | 2 | 2 | 2026-04-07 |
| Beckman Coulter, Inc. | 2 | 2 | 2026-03-13 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 86706 | CPT | — | High | Hepatitis B antibody (HBsAb) quantitative assay; standard hepatitis B serology code |
| 86704 | CPT | — | Medium | Hepatitis B surface antigen antibody (anti-HBs) qualitative/quantitative detection |
| Date | PMA # | Sponsor | Trade name | Type |
|---|---|---|---|---|
| 2022-07-27 | P210019 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) | Original |
| 2021-07-14 | P200017 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-HBe2 (aHBe2) assay | Original |
| 2021-02-23 | P190034 | Roche Diagnostics | Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck | Original |
| 2021-02-03 | P190005 | Roche Diagnostics | Elecsys Anti-HBe, PreciControl Anti-HBe | Original |
| 2020-08-29 | P180049 | DiaSorin, Inc. | LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe | Original |
| 2020-08-29 | P180045 | DiaSorin, Inc. | LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM | Original |
| 2020-02-21 | P180039 | DiaSorin, Inc. | LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers | Original |
| 2020-01-02 | P180038 | DiaSorin, Inc. | LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc | Original |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-04-07 | K260049 | Roche Diagnostics | Elecsys Anti-HBc IgM |
| 2026-04-07 | K260046 | Roche Diagnostics | Elecsys Anti-HBc II |
| 2026-03-13 | K254059 | Beckman Coulter, Inc. | Access anti-HBc IgM |
| 2026-02-19 | K253687 | Beckman Coulter, Inc. | Access anti-HBc Total |