Device class
Class II
Regulation 866.1640
Total clearances
7
2021-12-15 → 2025-02-27
Definition
What is Susceptibility Test Plate, Antifungal
The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Classification details
Medical specialty
Microbiology
Regulation number
866.1640
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 |
| 87103 |
CPT
|
— |
High
|
Antifungal susceptibility studies by microdilution method |
Pulse
Most recent 510(k) clearances