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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 3 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli O76 serum high titer, 1 mL 81479
FDA UDI
Class IActive
ImmuLex Pneumococcus Factor 25c, 1.5 mL 98926
FDA UDI
Class IActive
Salmonella Phase H:Rz77 serum, 3 mL 40362
FDA UDI
Class IIActive
E. coli reference strain O9 81842
FDA UDI
Class IActive
Salm. Phase Inversion H:Rz34 serum, 3 mL 53950
FDA UDI
Class IIActive
ImmuLex H. influenzae type a antiserum, 1, 5 mL 91460
FDA UDI
Class IIUnknown
Pneumococcus Factor 9e serum high titer, 1 mL 99022
FDA UDI
Class IActive
E. coli reference strain K11 85369
FDA UDI
Class IActive
Salmonella Gruppe O:51 serum, 3 mL 40249
FDA UDI
Class IIActive
E. coli H55 serum, 5 mL 54477
FDA UDI
Class IActive
E. coli O90 serum, 3 mL 45827
FDA UDI
Class IUnknown
Pneumococcus Factor 15c serum high titer, 1 mL 96730
FDA UDI
Class IActive
S. pneumoniae reference strain 20 82222
FDA UDI
Class IActive
E. coli O22 serum high titer, 1 mL 81385
FDA UDI
Class IActive
E. coli reference strain F5 88684
FDA UDI
Class IActive
E. coli reference strain K36 81982
FDA UDI
Class IActive
E. coli O178 serum, 1 mL 85174
FDA UDI
Class IActive
E. coli reference strain H35 85352
FDA UDI
Class IActive
E. coli reference strain O152 82287
FDA UDI
Class IActive
E. coli reference strain O78 82063
FDA UDI
Class IActive
Pneumococcus Group 24 serum, 1 mL 16914
FDA UDI
Class IActive
Salm. Phase Inversion SG 1 serum, 3 mL 40363
FDA UDI
Class IIActive
S. pneumoniae reference strain 19B 82220
FDA UDI
Class IActive
E. coli reference strain O141ac 82275
FDA UDI
Class IActive
E. coli O5 serum, 3 mL 45744
FDA UDI
Class IUnknown
S. pneumoniae reference strain 3 82177
FDA UDI
Class IActive
E. coli reference strain O133 82266
FDA UDI
Class IActive
Salmonella Phase H:Rz27 serum, 3 mL 40353
FDA UDI
Class IIActive
E. coli O91 serum, 3 mL 45828
FDA UDI
Class IUnknown
E. coli reference strain H3 85338
FDA UDI
Class IActive
E. coli O141ac serum high titer, 1 mL 81596
FDA UDI
Class IActive
E. coli OK O139 serum, 3 mL 72686
FDA UDI
Class IActive
S. pneumoniae reference strain 17F 82212
FDA UDI
Class IActive
E. coli reference strain O76 82060
FDA UDI
Class IActive
Pneumococcus Factor 17b serum high titer, 1 mL 99850
FDA UDI
Class IActive
Pneumococcus Factor 6d serum high titer, 1 mL 96735
FDA UDI
Class IActive
Salmonella Phase H:Rz76 serum, 3 mL 40361
FDA UDI
Class IIActive
E. coli reference strain O107 82113
FDA UDI
Class IActive
ImmuView S. pneumoniae and L. pneumophila urinary antigen test 10557
FDA UDI
Class IIActive
Pneumococcus Type 34 serum, 1 mL 16759
FDA UDI
Class IActive
E. coli O184 serum high titer, 1 mL 81634
FDA UDI
Class IActive
E. coli O167 serum high titer, 1 mL 81456
FDA UDI
Class IActive
Salmonella O Group Pool OME serum, 1 mL 73526
FDA UDI
Class IIUnknown
Pneumococcus Factor 24c serum, 1 mL 16971
FDA UDI
Class IActive
S. pneumoniae reference strain 22A 82225
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool E serum, 1.5 mL 52394
FDA UDI
Class IActive
E. coli reference strain O99 82105
FDA UDI
Class IActive
Shigella flexneri pool serum, 3 mL 66443
FDA UDI
Class IIUnknown
E. coli O113 serum high titer, 1 mL 81529
FDA UDI
Class IActive
E. coli O125abc serum, 3 mL 46854
FDA UDI
Class IUnknown

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