Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Microbiology · 21 CFR 866.3183
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.
Recent MDR events
8 adverse event reports on file
- ALINITY M EBV AMP KITJan 20, 2026MalfunctionAbbott Molecular, Inc.3005248192-2026-00009
- EPSTEIN-BARR VIRUS DNA, QUANTITATIVE, REAL-TIME PCR, PLASMANov 5, 2025MalfunctionRoche Diagnostics23692525
- EPSTEIN BARR VIRUS DNA, QN REAL TIME PCR,PLASMAAug 28, 2025MalfunctionQuest DiagnosticsMW5175381
- COBAS® BKV (192)Nov 11, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-03266
- ALINITY M EBV AMP KITApr 4, 2024MalfunctionAbbott Molecular, Inc.3005248192-2024-00079
- ALINITY M EBV AMP KITApr 4, 2024MalfunctionAbbott Molecular, Inc.3005248192-2024-00073
- ALINITY M EBV AMP KITMar 1, 2024MalfunctionAbbott Molecular, Inc.3005248192-2024-00055
- ALINITY M EBV AMPLIFICATION REAGENT KITFeb 27, 2023MalfunctionAbbott Molecular, Inc.3005248192-2023-00118
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Rpi Biosolutions
Mundelein, IL, US
Diasorin Molecular Llc
CYPRESS, CA, US
Abbott Molecular, Inc.
Des Plaines, IL, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
4 clearances for this product code
- Abbott Molecular, Inc.Jul 28, 2025
K243489 · Alinity m EBV (09N43-095)
- Abbott Molecular, Inc.Jul 15, 2022
K212778 · 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)
- Roche Molecular Systems, Inc.Jan 29, 2021
K203220 · cobas BKV
- Roche Molecular Systems, Inc.Jul 30, 2020
DEN200015 · cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit