Infectious diseasesControls/standards/calibrators - (infect. immunology/NAT)Controls - infect. immunology
Hepatitis virus controls - inf.imm.
EMDN code W0105080802
Manufacturers registered in Europe (EUDAMED) 10
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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 |
|---|---|---|---|
| Abbott Laboratories Present in Europe in other categories | United States | ARCHITECT Alinity | K222850 (2023) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Elecsys Anti-HAV II Elecsys AntiHAV Assay Elecsys AntiHAV IgM Elecsys Anti-HAV IgM Elecsys Anti-HAV | K260048 (2026) |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K060770 (2006) |
| Biokit, S.A. Present in Europe in other categories | Spain | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
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- Parent category : Controls - infect. immunology64 manufacturers