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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 9 of 29
DeviceModel / ReferenceRegistriesClassStatus
Pneumococcus Factor 10b serum, 1 mL 16939
FDA UDI
Class IActive
E. coli O110 serum, 1 mL 85106
FDA UDI
Class IActive
E. coli O70 serum high titer, 1 mL 81474
FDA UDI
Class IActive
S. pneumoniae reference strain 19F 82218
FDA UDI
Class IActive
Salmonella H Phase Pool HMF serum, 3 mL 40296
FDA UDI
Class IIActive
Shigella sonnei pool serum, 3 mL 66445
FDA UDI
Class IIUnknown
Pneumococcus Group 23 serum, 1 mL 16913
FDA UDI
Class IActive
E. coli reference strain O121 82130
FDA UDI
Class IActive
E. coli O178 serum high titer, 1 mL 81628
FDA UDI
Class IActive
Pneumococcus Factor 19c serum high titer, 1 mL 99025
FDA UDI
Class IActive
Pneumococcus Pool A serum, 1 mL 16725
FDA UDI
Class IActive
E. coli O77 serum, 1 mL 85071
FDA UDI
Class IActive
E. coli O61 serum, 1 mL 85057
FDA UDI
Class IActive
Pneumococcus Type 42 serum, 1 mL 16765
FDA UDI
Class IActive
Salm. H Phase Pool H:q, s, t, p, u serum, 1 mL 73542
FDA UDI
Class IIActive
E. coli O124 serum high titer, 1 mL 81437
FDA UDI
Class IActive
E. coli O128abc serum, 1 mL 85124
FDA UDI
Class IActive
Salmonella Factor O:5 serum, 3 mL 40272
FDA UDI
Class IIActive
E. coli reference strain H29 85350
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool G serum, 1.5 mL 52396
FDA UDI
Class IActive
Pneumococcus Type 34 serum high titer, 1 mL 96722
FDA UDI
Class IActive
E. coli reference strain K93 85376
FDA UDI
Class IActive
E. coli O95 serum, 1 mL 85089
FDA UDI
Class IActive
Pneumococcus Factor 10d serum high titer, 1 mL 91583
FDA UDI
Class IUnknown
Salmonella Phase H:z10 serum, 3 mL 40308
FDA UDI
Class IIActive
Salm. O Group Pool O3 Comp. serum, 3 mL 40219
FDA UDI
Class IIActive
E. coli reference strain H40 85356
FDA UDI
Class IActive
E. coli reference strain O153 82288
FDA UDI
Class IActive
S. pneumoniae reference strain 5 82179
FDA UDI
Class IActive
E. coli O115 serum high titer, 1 mL 81435
FDA UDI
Class IActive
Pneumoccoccus CWPS Multi, 10 mg 68866
FDA UDI
Class IActive
E. coli O171 serum, 1 mL 85167
FDA UDI
Class IActive
E. coli reference strain H6 81936
FDA UDI
Class IActive
E. coli reference strain K46 81992
FDA UDI
Class IActive
Salmonella Factor H:z16 serum, 3 mL 40346
FDA UDI
Class IIActive
E. coli O26 serum, 1 mL 85023
FDA UDI
Class IUnknown
E. coli O137 serum, 1 mL 85133
FDA UDI
Class IActive
E. coli O104 serum, 3 mL 45840
FDA UDI
Class IActive
Salmonella Phase H:z60 serum, 3 mL 40609
FDA UDI
Class IIActive
ImmuLex S. pneumoniae Omni kit, 1 mL 91398
FDA UDI
Class IActive
E. coli O111 serum, 3 mL 45847
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool A serum, 1.5 mL 52390
FDA UDI
Class IActive
E. coli O26 serum high titer, 1 mL 81413
FDA UDI
Class IActive
Pneumococcus Type 3 serum high titer, 1 mL 76858
FDA UDI
Class IActive
Pneumococcus Group 18 serum, 1 mL 16910
FDA UDI
Class IActive
E. coli reference strain K32 81978
FDA UDI
Class IActive
S. pneumoniae reference strain 35C 82250
FDA UDI
Class IActive
S. pneumoniae reference strain 27 82234
FDA UDI
Class IActive
Salmonella Phase H:b serum, 3 mL 23847
FDA UDI
Class IIActive
E. coli O75 serum high titer, 1 mL 81478
FDA UDI
Class IActive

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