Device class
Class II
Regulation 866.3987
Total clearances
12
2024-10-07 → 2026-07-10
Definition
What is Multi-Analyte Respiratory Virus Antigen Detection Test
A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.
Classification details
Medical specialty
Microbiology
Regulation number
866.3987
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 |
| 87807 |
CPT
|
— |
High
|
CPT for detection of respiratory virus antigen by immunoassay at point of care |
Pulse
Most recent 510(k) clearances