Device class
Class II
Regulation 862.1675
Total clearances
3
2020-07-28 → 2023-11-21
Definition
What is Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1675
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 |
| 80320 |
CPT
|
— |
Medium
|
Drugs of abuse testing; oral fluid specimen collection device support |
| 80323 |
CPT
|
— |
Medium
|
Alcohol marker testing via oral fluid collection method |
Pulse
Most recent 510(k) clearances