Device class
Class II
Regulation 866.3365
Total clearances
4
2020-03-18 → 2025-04-18
Definition
What is Gram-Negative Bacteria And Associated Resistance Markers
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Classification details
Medical specialty
Microbiology
Regulation number
866.3365
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
|
— |
High
|
Pathogen panel, bacterial, multiplex nucleic acid amplification |
| 87471 |
CPT
|
— |
Medium
|
Gram stain for bacteria; foundational bacterial ID |
Pulse
Most recent 510(k) clearances