Device class
Class II
Regulation 866.3328
Total clearances
7
2020-02-18 → 2026-01-15
Definition
What is Devices Detecting Influenza A, B, And C Virus Antigens
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Classification details
Medical specialty
Microbiology
Regulation number
866.3328
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Bd
|
2 |
0 |
2023-12-05 |
|
SEKISUI Diagnostics, LLC |
2 |
0 |
2025-04-18 |
|
Nano-Ditech Corporation
|
1 |
1 |
2026-01-15 |
|
Innovita (Tangshan) Biological Technology Co., Ltd. |
1 |
0 |
2025-07-03 |
|
Access Bio, Inc.
|
1 |
0 |
2020-02-18 |
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 |
| 87804 |
CPT
|
— |
High
|
Influenza A, B, and C virus antigen detection by immunoassay |
| 87901 |
CPT
|
— |
Medium
|
Rapid respiratory viral antigen detection panel if bundled with influenza |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-01-15 |
K252283 |
Nano-Ditech Corporation
|
Nano-Check Influenza A+B Test |
| 2025-07-03 |
K250398 |
Innovita (Tangshan) Biological Technology Co., Ltd.
|
Innovita Flu A/B Antigen Rapid Test |
| 2025-04-18 |
K241188 |
SEKISUI Diagnostics, LLC
|
Acucy® Influenza A&B Test with the Acucy® 2 System |
| 2023-12-05 |
K232434 |
Bd
|
BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit |
| 2023-01-27 |
K223016 |
Bd
|
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit |
| 2020-04-03 |
K192719 |
SEKISUI Diagnostics, LLC
|
Osom Ultra Plus Flu A&B Test Kit |
| 2020-02-18 |
K191514 |
Access Bio, Inc.
|
CareStart Flu A&B Plus |