Device class
Class II
Regulation 866.1650
Total clearances
3
2024-02-08 → 2025-03-28
Definition
What is Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Classification details
Medical specialty
Microbiology
Regulation number
866.1650
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Selux Diagnostics, Inc.
|
2 |
0 |
2025-03-28 |
|
Avails Medical, Inc. |
1 |
0 |
2024-02-08 |
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 |
| 87077 |
CPT
|
— |
High
|
Blood culture for aerobic organism; organism preparation for susceptibility testing |
| 87181 |
CPT
|
— |
Medium
|
Antimicrobial susceptibility testing; device prepares inoculum for testing |
Pulse
Most recent 510(k) clearances