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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 5 of 29
DeviceModel / ReferenceRegistriesClassStatus
Pneumococcus Group 9 serum, 1 mL 16903
FDA UDI
Class IActive
E. coli O57 serum high titer, 1 mL 81463
FDA UDI
Class IActive
Salm. Phase Inversion H:z41 serum, 3 mL 40388
FDA UDI
Class IIActive
E. coli O105 serum, 1 mL 85100
FDA UDI
Class IActive
Pneumococcus Type 37 serum, 1 mL 16761
FDA UDI
Class IActive
E. coli O126 serum, 1 mL 85122
FDA UDI
Class IActive
E. coli reference strain O65 82049
FDA UDI
Class IActive
E. coli O156 serum high titer, 1 mL 81603
FDA UDI
Class IActive
Salmonella H Phase Pool HMD serum, 3 mL 40294
FDA UDI
Class IIActive
E. coli O157 serum high titer, 1 mL 81451
FDA UDI
Class IActive
S. pneumoniae reference strain 9V 82191
FDA UDI
Class IActive
Salmonella Factor O:25 serum, 3 mL 40285
FDA UDI
Class IIActive
E. coli O183 serum, 1 mL 85179
FDA UDI
Class IActive
E. coli O149 serum, 3 mL 45888
FDA UDI
Class IActive
E. coli reference strain O111 82118
FDA UDI
Class IActive
Salmonella Group O:1, 3, 19 serum, 3 mL 23843
FDA UDI
Class IIActive
E. coli O101 serum, 3 mL 45837
FDA UDI
Class IUnknown
Salmonella Phase H:z55 serum, 3 mL 40320
FDA UDI
Class IIActive
E. coli reference strain O137 82270
FDA UDI
Class IActive
Pneumococcus Group 10 serum, 1 mL 16904
FDA UDI
Class IActive
E. coli reference strain O178 81925
FDA UDI
Class IActive
E. coli O93 serum high titer, 1 mL 81497
FDA UDI
Class IActive
E. coli O27 serum high titer, 1 mL 81415
FDA UDI
Class IActive
E. coli reference strain O148 82283
FDA UDI
Class IActive
E. coli O101 serum, 1 mL 85095
FDA UDI
Class IActive
E. coli reference strain O14 81847
FDA UDI
Class IActive
S. pneumoniae reference strain 9A 82188
FDA UDI
Class IActive
Pneumococcus Factor 22c serum, 1 mL 16967
FDA UDI
Class IActive
E. coli H38 serum, 5 mL 54454
FDA UDI
Class IActive
E. coli O68 serum high titer, 1 mL 81472
FDA UDI
Class IActive
E. coli reference strain H34 81950
FDA UDI
Class IActive
E. coli O177 serum high titer, 1 mL 81627
FDA UDI
Class IActive
E. coli O21 serum, 1 mL 85018
FDA UDI
Class IActive
Salmonella H Phase Pool H:G serum, 3 mL 40299
FDA UDI
Class IIActive
E. coli reference strain O125ab 82133
FDA UDI
Class IActive
S. pneumoniae reference strain 33B 82243
FDA UDI
Class IActive
E. coli O154 serum high titer, 1 mL 81601
FDA UDI
Class IActive
E. coli H49 serum, 5 mL 54470
FDA UDI
Class IActive
E. coli O119 serum, 1 mL 85116
FDA UDI
Class IActive
E. coli O12 serum high titer, 1 mL 81373
FDA UDI
Class IActive
Salmonella Phase H:l, w serum, 3 mL 53830
FDA UDI
Class IIUnknown
E. coli O70 serum, 1 mL 85065
FDA UDI
Class IActive
Pneumococcus Factor 25c serum, 1 mL 16975
FDA UDI
Class IActive
S. pneumoniae reference strain 2 82176
FDA UDI
Class IActive
E. coli H18 serum, 5 mL 54422
FDA UDI
Class IActive
Salmonella O Group Pool OMC serum, 1 mL 73524
FDA UDI
Class IIUnknown
E. coli O6 serum high titer, 1 mL 81357
FDA UDI
Class IActive
S. pneumoniae reference strain 23F 82226
FDA UDI
Class IActive
E. coli reference strain O127 82137
FDA UDI
Class IActive
E. coli OK O142 serum, 3 mL 44307
FDA UDI
Class IActive

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