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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 7 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli O119 serum high titer, 1 mL 81436
FDA UDI
Class IActive
E. coli reference strain O139 82272
FDA UDI
Class IActive
Salmonella Phase H:z65 serum, 3 mL 40324
FDA UDI
Class IIActive
E. coli reference strain K17 85372
FDA UDI
Class IActive
E. coli OKO 45 reference strain 87256
FDA UDI
Class IActive
E. coli reference strain H52 81959
FDA UDI
Class IActive
E. coli O177 serum, 1 mL 85173
FDA UDI
Class IActive
Pneumococcus Factor 33e serum, 1 mL 16982
FDA UDI
Class IActive
E. coli O34 serum high titer, 1 mL 81392
FDA UDI
Class IActive
Pneumococcus Type 5 serum, 1 mL 16748
FDA UDI
Class IActive
Pneumococcus Pool P serum, 1 mL 16739
FDA UDI
Class IActive
Salmonella Phase H:l, v serum, 3 mL 53829
FDA UDI
Class IIUnknown
E. coli reference strain H10 85342
FDA UDI
Class IActive
S. pneumoniae reference strain 12F 82201
FDA UDI
Class IActive
E. coli reference strain H45 81953
FDA UDI
Class IActive
Salmonella O Group Pool OMG serum, 3 mL 40218
FDA UDI
Class IIActive
E. coli O135 serum high titer, 1 mL 81542
FDA UDI
Class IActive
Salmonella O Group Pool OMB serum, 1 mL 73523
FDA UDI
Class IIActive
Pneumococcus Factor 11f serum, 1 mL 16945
FDA UDI
Class IActive
E. coli reference strain K39 81985
FDA UDI
Class IActive
E. coli O106 serum, 1 mL 85102
FDA UDI
Class IActive
Pneumococcus Factor 18f serum high titer, 1 mL 96732
FDA UDI
Class IActive
E. coli O142 serum, 1 mL 85138
FDA UDI
Class IActive
Pneumococcus Pool R serum, 1 mL 16741
FDA UDI
Class IActive
E. coli reference strain K100 82007
FDA UDI
Class IActive
E. coli reference strain O5 81838
FDA UDI
Class IActive
ImmuLex Pneumococcus Factor 6b, 1.5 mL 77334
FDA UDI
Class IActive
Pneumococcus Factor 9e serum high titer, 1 mL 99032
FDA UDI
Class IUnknown
Pneumococcus Group 15 serum, 1 mL 16907
FDA UDI
Class IActive
E. coli O78 serum high titer, 1 mL 81427
FDA UDI
Class IActive
Pneumococcus Group 33 serum high titer, 1 mL 76916
FDA UDI
Class IActive
S. Stanley reference strain 82165
FDA UDI
Class IIActive
E. coli O18ab serum high titer, 1 mL 81363
FDA UDI
Class IActive
E. coli reference strain O182 81930
FDA UDI
Class IActive
E. coli reference strain O91 82098
FDA UDI
Class IActive
E. coli O152 serum, 1 mL 85148
FDA UDI
Class IActive
E. coli reference strain O29 81867
FDA UDI
Class IActive
E. coli reference strain O125ac 82134
FDA UDI
Class IActive
E. coli reference strain K19 85374
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool I serum, 1.5 mL 52398
FDA UDI
Class IActive
E. coli H30 serum, 5 mL 54438
FDA UDI
Class IActive
E. coli O126 serum high titer, 1 mL 81439
FDA UDI
Class IActive
ImmuLex H. influenzae type c antiserum, 1, 5 mL 91461
FDA UDI
Class IIUnknown
E. coli O139 serum, 1 mL 85135
FDA UDI
Class IUnknown
E. coli reference strain O63 82047
FDA UDI
Class IActive
Pneumococcus Pool I serum, 1 mL 16737
FDA UDI
Class IActive
Pneumococcus Factor 35b serum high titer, 1 mL 96739
FDA UDI
Class IActive
S. pneumoniae reference strain 25F 82232
FDA UDI
Class IActive
E. coli H27 serum, 5 mL 54433
FDA UDI
Class IActive
E. coli O108 serum, 1 mL 85104
FDA UDI
Class IActive

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