Device class
Class II
Regulation 862.1675
Total clearances
3
2020-01-14 → 2022-10-27
Definition
What is Dna Specimen Collection, Saliva
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1675
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
DNA Genotek, Inc.
|
2 |
0 |
2022-10-27 |
|
Ancestry Genomics, Inc. |
1 |
0 |
2020-08-13 |
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 |
| 81479 |
CPT
|
— |
Medium
|
Unlisted molecular pathology procedure |
| 82107 |
CPT
|
— |
Medium
|
Specimen collection for clinical laboratory; venipuncture |
Pulse
Most recent 510(k) clearances