Device class
Class II
Regulation 866.3183
Total clearances
4
2020-07-30 → 2025-07-28
Definition
What is Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.
Classification details
Medical specialty
Microbiology
Regulation number
866.3183
Trend
Clearance volume by quarter
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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 |
| 87497 |
CPT
|
— |
High
|
Epstein-Barr virus (EBV) DNA quantitative nucleic acid test by amplification is standard CPT |
| 87798 |
CPT
|
— |
Medium
|
Infectious disease nucleic acid amplification testing (NAAT); alternative code for EBV quantitation |
Pulse
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