Device class
Class II
Regulation 866.5100
Total clearances
3
2020-12-11 → 2023-08-31
Classification details
Medical specialty
Immunology
Regulation number
866.5100
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 |
| 86780 |
CPT
|
— |
High
|
Standard CPT for anti-DNA (anti-double stranded DNA) antibody test |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-08-31 |
K231616 |
Zeus Scientific
|
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine |
| 2023-05-26 |
K203599 |
Immuno Concepts, N.A. , Ltd.
|
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System |
| 2020-12-11 |
K192916 |
Inova Diagnostics, Inc.
|
NOVA Lite DAPI dsDNA Crithidia luciliae Kit |