510(k) DEN200015
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 30, 2020
- Date Received
- March 2, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Device Class
- Class II
- Regulation Number
- 866.3183
- Review Panel
- MI
- Submission Type
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.