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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 11 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli H7 serum, 5 mL 54406
FDA UDI
Class IActive
E. coli O173 serum high titer, 1 mL 81623
FDA UDI
Class IActive
E. coli reference strain F6 85335
FDA UDI
Class IActive
S. pneumoniae reference strain 41F 82256
FDA UDI
Class IActive
E. coli reference strain K10 85368
FDA UDI
Class IActive
E. coli O73 serum high titer, 1 mL 81476
FDA UDI
Class IActive
E. coli H56 serum, 5 mL 54479
FDA UDI
Class IActive
E. coli reference strain O164 82300
FDA UDI
Class IActive
E. coli reference strain H49 81957
FDA UDI
Class IActive
E. coli OK O114 serum, 3 mL 44300
FDA UDI
Class IActive
E. coli O95 serum high titer, 1 mL 81498
FDA UDI
Class IActive
E. coli O128abc serum high titer, 1 mL 81441
FDA UDI
Class IActive
Salmonella Phase H:Rz72 serum, 3 m 40360
FDA UDI
Class IIActive
Salmonella Factor H:z28 serum, 3 mL 40349
FDA UDI
Class IIActive
ImmuLex H. influenzae type e antiserum, 1, 5mL 91464
FDA UDI
Class IIUnknown
E. coli O38 serum high titer, 1 mL 81396
FDA UDI
Class IActive
E. coli O97 serum, 1 mL 85091
FDA UDI
Class IActive
E. coli reference strain O154 82289
FDA UDI
Class IActive
E. coli reference strain O184 81932
FDA UDI
Class IActive
E. coli O46 serum high titer, 1 mL 81403
FDA UDI
Class IActive
E. coli reference strain O41 81879
FDA UDI
Class IActive
Salmonella Gruppe O:35 serum, 3 mL 40236
FDA UDI
Class IIActive
E. coli O29 serum high titer, 1 mL 81423
FDA UDI
Class IActive
E. coli O16 serum, 1 mL 85012
FDA UDI
Class IActive
E. coli O48 serum, 1 mL 85044
FDA UDI
Class IActive
ImmuLex S. pneumoniae Type 14, 1.5 mL 77326
FDA UDI
Class IActive
Pneumococcus Factor 9d serum high titer, 1 mL 99031
FDA UDI
Class IUnknown
E. coli reference strain O116 82124
FDA UDI
Class IActive
E. coli H12 serum, 5 mL 54414
FDA UDI
Class IActive
E. coli H16 serum, 5 mL 54419
FDA UDI
Class IActive
E. coli O146 serum, 1 mL 85142
FDA UDI
Class IActive
E. coli reference strain O156 82291
FDA UDI
Class IActive
ImmuLex Strep-B kit, 10 x 1.5 mL 54991
FDA UDI
Class IActive
E. coli reference strain O52 82033
FDA UDI
Class IActive
E. coli O174 serum, 1 mL 85170
FDA UDI
Class IActive
E. coli reference strain O175 81922
FDA UDI
Class IActive
E. coli reference strain H53 81961
FDA UDI
Class IActive
ImmuLex Streptococcus Group B, 1.5 mL 73259
FDA UDI
Class IUnknown
S. pneumoniae reference strain 15F 82206
FDA UDI
Class IActive
Pneumococcus Type 48 serum, 1 mL 16771
FDA UDI
Class IActive
E. coli O142 serum high titer, 1 mL 81443
FDA UDI
Class IActive
E. coli O113 serum, 3 mL 45850
FDA UDI
Class IUnknown
Pneumococcus Factor 15e serum, 1 mL 16952
FDA UDI
Class IActive
Pneumococcus Type 46 serum, 1 mL 16770
FDA UDI
Class IActive
E. coli H29 serum, 5 mL 54435
FDA UDI
Class IActive
E. coli O125abc serum, 1 mL 85121
FDA UDI
Class IActive
E. coli reference strain K54 82000
FDA UDI
Class IActive
E. coli reference strain K38 81984
FDA UDI
Class IActive
E. coli O149 serum, 1 mL 85145
FDA UDI
Class IUnknown
Salmonella Phase H:Rz66 serum, 3 mL 48959
FDA UDI
Class IIActive

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