Device class
Class II
Regulation 866.3130
Total clearances
4
2021-09-09 → 2025-02-28
Definition
What is C. Difficile Toxin Gene Amplification Assay
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Classification details
Medical specialty
Microbiology
Regulation number
866.3130
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 |
| 87493 |
CPT
|
— |
High
|
Clostridium difficile toxin gene detection by amplification assay; standard C. difficile molecular testing code |
Pulse
Most recent 510(k) clearances