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Data / Medical devices / Germany / DEMEDITEC DIAGNOSTICS GmbH

DEMEDITEC DIAGNOSTICS GmbH: FDA-registered device maker in KIEL-WELLSEE Schleswig-Holstein, Germany, 3 510(k) clearances

DEMEDITEC DIAGNOSTICS GmbH is registered with the FDA (registration 3005542422) in KIEL-WELLSEE Schleswig-Holstein, Germany. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2008. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch DEMEDITEC DIAGNOSTICS GmbH
FDA registration number
3005542422
Address
Lise-Meitner-Strasse 2, KIEL-WELLSEE Schleswig-Holstein, Germany, D-24145
Owner or operator
DEMEDITEC DIAGNOSTICS (9083404)
Roles
Manufacturer, Repackager or relabeler
First device listed
February 24, 2006
Registered through
2026
Brand names listed
Androstenedione ELISA, C-Peptide ELISA, DEECHG0130 Echinococcus IgG, DEMEDITEC DHEA-S ELISA KIT, DEMEDITEC ESTRIOL TEST SYSTEM, DEMEDITEC PROGESTERONE ELISA KIT, DHEA ELISA, DHEA-S ELISA and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigen, Agglutinating, Echinococcus Spp.GPF1Repackager or relabeleraccessdata.fda.gov
Antigen, Fluorescent Antibody Test, Schistosoma MansoniGNH1Repackager or relabeleraccessdata.fda.gov
Antisera, Cf, Adenovirus 1-33GOA1Repackager or relabeleraccessdata.fda.gov
Antisera, Cf, Parainfluenza Virus 1-4GQT1Repackager or relabeleraccessdata.fda.gov
Antisera, Hai, Influenza Virus A, B, CGNS1Repackager or relabeleraccessdata.fda.gov
Elisa, Trichinella SpiralisMDT1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps VirusLJY1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola IggLJB1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, AndrostenedioneCIZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, CorticosteroneCHA1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Manufactureraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstriolCGI1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Respiratory Syncytial Virus - ElisaMCE1Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 29, 2008K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJLXSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov
January 27, 2006K052649DRG SLV TESTOSTERONE ELISA TESTCDZSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov
April 17, 2000K000043DRG AURICA ELISA TESTOSTERONE KITCDZSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated January 29, 2008. 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.