Infectious diseasesOther virology tests (infect. immunology/NAT)Herpes simplex virus
Hsv - NA reagents
EMDN code W0105040311
Manufacturers registered in Europe (EUDAMED) 35
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
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Other manufacturers known in the United States (FDA) 4
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Roche Molecular Systems, Inc. | United States | cobas® 4800 System Lysis Kit cobas® 4800 Systems Internal Control Kit | K150617 (2015) |
| DIASORIN MOLECULAR LLC Present in Europe in other categories | United States | Simplexa™ HSV 1 & 2 Positive Control Pack Simplexa™ HSV 1 & 2 Direct | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Vela Diagnostics USA, Inc. | United States | – | K172509 (2018) |
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