QLX
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3183
- Medical specialty
- Microbiology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |
| cobas BKV (K203220) | Roche Molecular Systems, Inc. | 2021-01-29 |
| cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015) | Roche Molecular Systems, Inc. | 2020-07-30 |
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Every clearance here is in the API, with alerts when new ones post.