Device class
Class II
Regulation 866.4000
Total clearances
3
2023-03-22 → 2026-08-07
Definition
What is Multiplex Nucleic Acid Detection System For Biothreat Agents
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens
Classification details
Medical specialty
Immunology
Regulation number
866.4000
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 |
| 87798 |
CPT
|
— |
Medium
|
Biothreat agent nucleic acid detection; multiplex pathogen detection methodology |
| 87799 |
CPT
|
— |
Medium
|
Unlisted microbiology/immunology procedure; novel biothreat detection system may require unlisted code |
Pulse
Most recent 510(k) clearances