Data / Medical devices / Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna (QLX): 6 FDA-registered makers in 2 countries
6 establishments in 2 countries are registered with the FDA to make Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna (product code QLX, Class 2, 21 CFR 866.3183). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 28, 2025, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QLX
- Device class
- 2
- Regulation
- 866.3183
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Switzerland | 1 |
Makers of Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 2 | January 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 2 | January 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer | 1 | July 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | July 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.