Device class
Class II
Regulation 866.3173
Total clearances
4
2026-02-19 → 2026-04-07
Definition
What is Qualitative And Quantitative Hepatitis B Virus Antibody Assays
In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Classification details
Medical specialty
Microbiology
Regulation number
866.3173
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
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 |
Class III
PMA records in this code (8)
| 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 |
Pulse
Most recent 510(k) clearances