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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 2 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli reference strain O28ab 81865
FDA UDI
Class IActive
E. coli reference strain K29 81975
FDA UDI
Class IActive
S. pneumoniae reference strain 10C 82195
FDA UDI
Class IActive
ImmuLex Streptococcus Group F, 1.5 mL 73262
FDA UDI
Class IUnknown
S. Hadar reference strain 82155
FDA UDI
Class IIActive
S. pneumoniae reference strain 35A 82248
FDA UDI
Class IActive
E. coli O123 serum high titer, 1 mL 81535
FDA UDI
Class IActive
S. pneumoniae reference strain 33C 82244
FDA UDI
Class IActive
E. coli O28ab serum high titer, 1 mL 81388
FDA UDI
Class IActive
E. coli reference strain O144 82279
FDA UDI
Class IActive
Salmonella O Group Pool OMG serum, 1 mL 73528
FDA UDI
Class IIUnknown
E. coli OK O126 serum, 3 mL 44304
FDA UDI
Class IActive
Salm. Phase Inversion H:Rz66 serum, 3 mL 48955
FDA UDI
Class IIActive
E. coli O138 serum, 3 mL 45877
FDA UDI
Class IUnknown
E. coli reference strain O43 & H2 81881
FDA UDI
Class IActive
E. coli H1 serum, 5 mL 54397
FDA UDI
Class IActive
Pneumococcus Factor 23c serum high titer 99323
FDA UDI
Class IActive
S. Agona reference strain 82151
FDA UDI
Class IIActive
E. coli reference strain H43 85359
FDA UDI
Class IActive
E. coli reference strain K27 81973
FDA UDI
Class IActive
E. coli reference strain O30 81868
FDA UDI
Class IActive
S. pneumoniae reference strain 13 82204
FDA UDI
Class IActive
Salmonella H Phase Pool H:L serum, 3 mL 40297
FDA UDI
Class IIActive
ImmuLex Pneumococcus Factor 15h, 1.5 mL 98928
FDA UDI
Class IActive
Salmonella Gruppe O:28 serum, 3 mL 40234
FDA UDI
Class IIActive
E. coli O157 serum, 3 mL 45896
FDA UDI
Class IActive
S. pneumoniae reference strain 46 82262
FDA UDI
Class IActive
E. coli O162 serum, 1 mL 85158
FDA UDI
Class IActive
E. coli O75 serum, 1 mL 85069
FDA UDI
Class IActive
Pneumococcus Factor 15b serum, 1 mL 16950
FDA UDI
Class IActive
Pneumococcus Factor 12b serum, 1 mL 16947
FDA UDI
Class IActive
E. coli O28ab serum, 1 mL 85025
FDA UDI
Class IActive
Salmonella Factor O:24, 25 serum, 3 mL 65334
FDA UDI
Class IIActive
E. coli reference strain H7 85341
FDA UDI
Class IActive
E. coli O131 serum high titer, 1 mL 81538
FDA UDI
Class IActive
E. coli H25 serum, 5 mL 54430
FDA UDI
Class IActive
E. coli reference strain O46 82027
FDA UDI
Class IActive
E. coli O44 serum high titer, 1 mL 81424
FDA UDI
Class IActive
Pneumococcus Factor 19c serum, 1 mL 16963
FDA UDI
Class IActive
Salmonella H Phase Pool HMG serum, 3 mL 48953
FDA UDI
Class IIActive
ImmuView S. pneumoniae and L. pneumophila urinary antigen test 2451
FDA UDI
Class IIActive
Pneumococcus Factor 23d serum, 1 mL 16970
FDA UDI
Class IActive
E. coli O80 serum, 1 mL 85074
FDA UDI
Class IActive
Pneumococcus Type 13 serum, 1 mL 16752
FDA UDI
Class IActive
E. coli O136 serum, 1 mL 85132
FDA UDI
Class IActive
S. pneumoniae reference strain 33A 82242
FDA UDI
Class IActive
E. coli reference strain K101 and F6 82008
FDA UDI
Class IActive
Salm. Phase Inversion H:z65 serum, 3 mL 40399
FDA UDI
Class IIActive
Salm. Phase Inversion H:z29 serum, 3 mL 40383
FDA UDI
Class IIActive
E. coli O113 serum, 1 mL 85110
FDA UDI
Class IActive

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