Device class
Class I
Regulation 862.1510
Total clearances
3
2025-01-10 → 2025-12-23
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1510
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 |
| 81005 |
CPT
|
— |
High
|
Urinalysis non-quantitative nitrite detection via diazo colorimetric method |
Pulse
Most recent 510(k) clearances