Data / Medical devices / Denmark / SSI Diagnostica A/S
SSI Diagnostica A/S: FDA-registered device maker in Hilleroed Hovedstaden, Denmark, 1 510(k) clearance
SSI Diagnostica A/S is registered with the FDA (registration 9611882) in Hilleroed Hovedstaden, Denmark. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611882
- FEI number
- 3002808078
- Address
- 2 Herredsvejen, Hilleroed Hovedstaden, Denmark, 3400
- Owner or operator
- SSI Diagnostica A/S (10052749)
- Roles
- Manufacturer
- First device listed
- September 27, 2016
- Registered through
- 2026
- Brand names listed
- Culture Media, Dermatophyte and C. albicans Real Time PCR kit, E. coli, E.coli strain, ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test, Pneumococcus, Pneumococcus strain, Reagent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Salmonella Spp. | GRL | 2 | Manufacturer | accessdata.fda.gov |
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Manufacturer | accessdata.fda.gov |
| Antigens, All Types, Escherichia Coli | GMZ | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Streptococcus Spp. | GTZ | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Escherichia Coli | GNA | 1 | Manufacturer | accessdata.fda.gov |
| Antisera, All Types, Streptococcus Pneumoniae | GWC | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Identification, Dermatophyte | JSR | 1 | Manufacturer | accessdata.fda.gov |
| Legionella, Spp., Elisa | MJH | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | 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 5, 2020 | K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | MJH | Substantially Equivalent | Ssi Diagnostica A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Selective And Differential
- All makers of Antisera, All Groups, Salmonella Spp.
- All makers of Kit, Identification, Dermatophyte
- All makers of Reagents, Specific, Analyte
- All makers of Antisera, All Types, Escherichia Coli
Updated March 5, 2020. 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.