Device class
Class I
Regulation 866.2560
Total clearances
3
2023-03-24 → 2026-05-28
Classification details
Medical specialty
Microbiology
Regulation number
866.2560
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 |
| 87081 |
CPT
|
— |
Medium
|
CPT for culture, bacterial, including aerobic and anaerobic; blood culturing system typically billed with culture codes |
| 87086 |
CPT
|
— |
Medium
|
CPT for culture, bacterial blood; alternative blood culture code depending on method |
Pulse
Most recent 510(k) clearances