Panels › Microbiology › Product code QLX · Class 2
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Regulation 866.3183
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QLX
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 2 | 0 |
| Roche Molecular Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2025 | K243489 | Alinity m EBV (09N43-095) Abbott Molecular, Inc. | QLX |
| 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. Abbott Molecular, Inc. | QLX |
| Jan 29, 2021 | K203220 | cobas BKV Roche Molecular Systems, Inc. | QLX |
| Jul 30, 2020 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. | QLX |
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