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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 6 of 29
DeviceModel / ReferenceRegistriesClassStatus
E. coli reference strain O54 82035
FDA UDI
Class IActive
E. coli reference strain O40 81878
FDA UDI
Class IActive
ImmuLex Streptococcus Type VI, 1, 5 mL 54988
FDA UDI
Class IActive
E. coli O188 serum, 1 mL 96274
FDA UDI
Class IActive
E. coli reference strain O38 81876
FDA UDI
Class IActive
Pneumococcus Factor 18e serum, 1 mL 16960
FDA UDI
Class IActive
E. coli O33 serum high titer, 1 mL 81391
FDA UDI
Class IActive
Shigella sonnei Fase I serum, 3 mL 66446
FDA UDI
Class IIUnknown
Pneumococcus Factor 18c serum high titer, 1 mL 99210
FDA UDI
Class IActive
Salmonella H Phase Pool HMC serum, 1 mL 73532
FDA UDI
Class IIUnknown
E. coli O96 serum, 1 mL 85090
FDA UDI
Class IActive
E. coli reference strain O183 81931
FDA UDI
Class IActive
S. pneumoniae reference strain 16A 82211
FDA UDI
Class IActive
Shigella dysentariae pool serum, 3 mL 66442
FDA UDI
Class IIUnknown
Salmonella Phase H:i serum, 3 mL 23850
FDA UDI
Class IIActive
E. coli reference strain O88 82090
FDA UDI
Class IActive
S. pneumoniae reference strain 25A 82233
FDA UDI
Class IActive
E. coli reference strain O71 82055
FDA UDI
Class IActive
Salm. Phase Inversion H:z52 serum, 3 mL 40391
FDA UDI
Class IIActive
E. coli O180 serum high titer, 1 mL 81630
FDA UDI
Class IActive
Salmonella Group O:63 serum, 3 mL 40263
FDA UDI
Class IIActive
Pneumococcus Factor 25b serum, 1 mL 16974
FDA UDI
Class IActive
Salmonella Gruppe O:59 serum, 3 mL 40258
FDA UDI
Class IIActive
Salmonella Gruppe O:18 serum, 3 mL 40232
FDA UDI
Class IIActive
S. pneumoniae reference strain 33D 82245
FDA UDI
Class IActive
E. coli O142 serum, 3 mL 45881
FDA UDI
Class IUnknown
E. coli reference strain O87 82089
FDA UDI
Class IActive
Pneumococcus Factor 17c serum, 1 mL 16957
FDA UDI
Class IActive
Pneumococcus Factor 6c serum high titer, 1 mL 99018
FDA UDI
Class IActive
E. coli O104 serum, 1 mL 85098
FDA UDI
Class IUnknown
Salmonella Gruppe O:43 serum, 3 mL 40242
FDA UDI
Class IIActive
Salmonella Factor O:6(1) serum, 3 mL 40273
FDA UDI
Class IIActive
E. coli H51 serum, 5 mL 54472
FDA UDI
Class IActive
Salmonella Phase H:z53 serum, 3 mL 40318
FDA UDI
Class IIActive
E. coli O58 serum, 1 mL 85054
FDA UDI
Class IActive
E. coli reference strain O180 81928
FDA UDI
Class IActive
E. coli reference strain O6 81839
FDA UDI
Class IActive
E. coli O138 serum, 1 mL 85134
FDA UDI
Class IActive
E. coli reference strain K18ab 85373
FDA UDI
Class IActive
Pneumococcus Group 16 serum, 1 mL 16908
FDA UDI
Class IActive
E. coli O45 serum, 1 mL 85042
FDA UDI
Class IUnknown
E. coli reference strain O145 82280
FDA UDI
Class IActive
Pneumococcus Factor 33b serum, 1 mL 16981
FDA UDI
Class IActive
S. Braenderup reference strain 82152
FDA UDI
Class IIActive
Pneumococcus Factor 7f serum, 1 mL 16931
FDA UDI
Class IActive
E. coli O18ab serum, 1 mL 85014
FDA UDI
Class IActive
S. pneumoniae reference strain 28F 82235
FDA UDI
Class IActive
Salm. Phase Inversion H:z54 serum, 3 mL 40393
FDA UDI
Class IIActive
S. pneumoniae reference strain 14 82205
FDA UDI
Class IActive
Salm. Phase Inversion SGZ4 serum, 3 mL 40370
FDA UDI
Class IIActive

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