IVD instrumentsNucleic acid testing instrumentsNucleic acid testing instruments except micro-arrays
Nucleic acid testing instruments except micro-arrays - consumables
EMDN code W02050185
Manufacturers registered in Europe (EUDAMED) 20
- 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.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 8
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 |
|---|---|---|---|
| Life Technologies Corporation | United States | 96WELL RETAINER & BASE FAST CAPILLARY ARRAY 24-CAP 50CM 96 WELL Retainer & Base STD CE-IVD SEPTA, 96 WELL CE-IVD 3500 DS-33 GeneScan™ Install Kit - Dx Pump cleaning Kit (3500Dx series) | K191030 (2020) |
| Roche Molecular Systems, Inc. | United States | cobas®4800 System Liquid Cytology Preparation Kit cobas® 4800 System Wash Buffer Kit cobas® 4800 HPV Amplification/Detection Kit cobas HPV Positive Control cobas®4800 HPV Controls Kit cobas HPV | P100020 (2026) |
| QIAGEN SCIENCES INC. Present in Europe in other categories | United States | hc2 High-Risk HPV DNA Test DML 3000 digene® Wash Buffer Concentrate hc2 HPV DNA Test | registered |
| HITACHI HIGH-TECH CORP. Present in Europe in other categories | Japan | – | registered |
| Hologic, Inc. Present in Europe in other categories | United States | – | P080015 (2018) |
| Qiagen Gaithersburg, Inc. | – | – | P890064 (2023) |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| STS Corporation | United States | – | registered |
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