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Ssi Diagnostica A/S

US

Last updated September 17, 2026

Part of SSI Diagnostica A/S

What Ssi Diagnostica A/S makes

The company produces in vitro diagnostic (IVD) reagents and controls for bacterial antigen detection, including antibodies and reference strains for *Escherichia coli*, *Streptococcus pneumoniae*, and *Salmonella* species. Products include specific bacterial serums (e.g., *E. coli* H3, *Pneumococcus* Group 11) and rapid immunochromatographic test (ICT) kits for respiratory bacteria identification. Control materials and culture isolates are also provided for laboratory validation and testing purposes.

These diagnostic products are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for in vitro diagnostics.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ssi Diagnostica A/S manufacture?

Ssi Diagnostica A/S specializes in in vitro diagnostic (IVD) reagents and controls. Their products focus on bacterial antigen detection, including antibodies, reference strains, and controls for *Escherichia coli*, *Streptococcus pneumoniae*, and *Salmonella* species. This includes specific bacterial serums (like *E. coli* H3 or *Pneumococcus* Group 11) and rapid immunochromatographic test (ICT) kits for identifying respiratory bacteria in clinical settings. They also provide control materials and culture isolates for laboratory validation.

Where is Ssi Diagnostica A/S based?

Ssi Diagnostica A/S is based in the United States. Their operations are aligned with U.S. regulatory requirements for in vitro diagnostics, ensuring compliance with applicable standards for their products.

Which regulatory registries list Ssi Diagnostica A/S’s devices?

Ssi Diagnostica A/S’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their authorized in vitro diagnostic products, including reagents, controls, and rapid test kits, under the U.S. regulatory framework.

How are Ssi Diagnostica A/S’s devices classified by regulatory authorities?

Ssi Diagnostica A/S’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the intended use and potential health impact of the product.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
ssidiagnostica.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+4548299100
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305684449

Catalogue (1426)

Page 4 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli O123 serum, 1 mL 85119
FDA UDI
Class IActive
E. coli O87 serum, 1 mL 85082
FDA UDI
Class IActive
E. coli O114 serum high titer, 1 mL 81432
FDA UDI
Class IActive
Salmonella Phase H:r serum, 3 mL 40304
FDA UDI
Class IIActive
E. coli O100 serum high titer, 1 mL 81516
FDA UDI
Class IActive
S. pneumoniae reference strain 47A 82264
FDA UDI
Class IActive
Pneumococcus Factor 16b serum, 1 mL 16954
FDA UDI
Class IActive
S. pneumoniae reference strain 11F 82196
FDA UDI
Class IActive
Salm. Phase Inversion H:z53 serum, 3 mL 40392
FDA UDI
Class IIActive
E. coli OK O125ac serum, 3 mL 44303
FDA UDI
Class IActive
E. coli reference strain H23 81943
FDA UDI
Class IActive
E. coli O33 serum, 1 mL 85030
FDA UDI
Class IActive
Salm. Phase Inversion H:z67 serum, 3 mL 48958
FDA UDI
Class IIActive
E. coli OK O127 serum, 3 mL 44305
FDA UDI
Class IActive
E. coli reference strain O134 82267
FDA UDI
Class IActive
S. pneumoniae reference strain 4 82178
FDA UDI
Class IActive
Salmonella Phase H:e, h serum, 3 mL 53844
FDA UDI
Class IIActive
E. coli O88 serum, 3 mL 45825
FDA UDI
Class IActive
Pneumococcus Factor 9d serum high titer, 1 mL 76920
FDA UDI
Class IActive
E. coli reference strain O163 82299
FDA UDI
Class IActive
S. pneumoniae reference strain 11D 82200
FDA UDI
Class IActive
Salmonella Gruppe O:53 serum, 3 mL 40251
FDA UDI
Class IIActive
ImmuLex Pneumococcus Factor 15c, 1.5 mL 98930
FDA UDI
Class IActive
Salmonella Phase H:z35 serum, 3 mL 40310
FDA UDI
Class IIActive
Salmonella Phase H:k serum, 3 mL 40303
FDA UDI
Class IIActive
E. coli O15 serum high titer, 1 mL 81361
FDA UDI
Class IActive
Salmonella Factor H:z23 serum, 3 mL 40347
FDA UDI
Class IIActive
Pneumococcus Omni serum, 1 mL 2438
FDA UDI
Class IActive
Salmonella Group O:6, 14, 24, 25 serum, 3 40229
FDA UDI
Class IIActive
Salmonella Gruppe O:56 serum, 3 mL 40254
FDA UDI
Class IIActive
Pneumococcus Factor 12b serum high titer, 1 mL 99307
FDA UDI
Class IActive
Salmonella H Phase Pool H:G serum, 1 mL 73539
FDA UDI
Class IIActive
Pneumococcus Factor 28b serum, 1 mL 16976
FDA UDI
Class IActive
Salmonella O Group Pool OMF serum, 1 mL 73527
FDA UDI
Class IIUnknown
E. coli O144 serum, 1 mL 85140
FDA UDI
Class IActive
E. coli O55 serum, 1 mL 85051
FDA UDI
Class IActive
Salmonella Group T2 serum, 3 mL 40268
FDA UDI
Class IIActive
E. coli O166 serum, 1 mL 85162
FDA UDI
Class IActive
ImmuLex Streptococcus Type V, 1, 5 mL 54987
FDA UDI
Class IActive
Pneumococcus Factor 10f serum, 1 mL 16941
FDA UDI
Class IActive
E. coli O17 serum high titer, 1 mL 81381
FDA UDI
Class IActive
E. coli O34 serum, 1 mL 85031
FDA UDI
Class IActive
ImmuLex H. influenzae type b antiserum, 1, 5 mL 85205
FDA UDI
Class IIUnknown
S. pneumoniae reference strain 48 82265
FDA UDI
Class IActive
Pneumococcus Factor 16c serum, 1 mL 16955
FDA UDI
Class IActive
E. coli O115 serum, 1 mL 85112
FDA UDI
Class IActive
E. coli O10 serum high titer, 1 mL 81370
FDA UDI
Class IActive
Pneumococcus Factor 15c serum, 1 mL 16951
FDA UDI
Class IActive
Salm. Multi Gr. Poly H serum, 3 mL 40290
FDA UDI
Class IIActive
Pneumococcus Factor 18d serum, 1 mL 16959
FDA UDI
Class IActive

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