Data / Medical devices / Denmark / Immudex, Aps
Immudex, Aps: FDA-registered device maker in Virum Hovedstaden, Denmark, 1 510(k) clearance
Immudex, Aps is registered with the FDA (registration 3008096179) in Virum Hovedstaden, Denmark. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 2, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008096179
- Address
- Bredevej 2A, Virum Hovedstaden, Denmark, DK-2830
- Owner or operator
- Immudex (10033288)
- Roles
- Manufacturer
- First device listed
- June 19, 2012
- Registered through
- 2026
- Brand names listed
- CAR Dextramer, CD1d Dextramer, CD1d Monomer, CMV Dextramer, Dextramer® CMV Kit, HLA-G Dextramer, HLA-G Monomer, Klickmer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Research Use Only/Pathology | OTU | N | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2017 | K153538 | Dextramer CMV Kit | GKZ | Substantially Equivalent | Immudex Aps | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Differential Cell
- All makers of Reagents, Specific, Analyte
- All makers of Research Use Only/Pathology
Updated March 2, 2017. 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.