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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 8 of 29
DeviceModel / ReferenceRegistriesClassStatus
S. Senftenberg reference strain 82164
FDA UDI
Class IIActive
E. coli reference strain O55 82036
FDA UDI
Class IActive
E. coli H45 serum, 5 mL 54464
FDA UDI
Class IActive
Salmonella Factor H:m serum, 3 mL 40332
FDA UDI
Class IIActive
E. coli O111 serum, 1 mL 85107
FDA UDI
Class IUnknown
E. coli O121 serum, 1 mL 85118
FDA UDI
Class IUnknown
E. coli O155 serum high titer, 1 mL 81602
FDA UDI
Class IActive
ImmuLex Pneumococcus Factor 23b, 1.5 mL 77342
FDA UDI
Class IActive
Salm. Phase Inversion H:z42 serum, 3 mL 40389
FDA UDI
Class IIActive
Pneumococcus Group 47 serum, 1 mL 16921
FDA UDI
Class IActive
Salmonella H Phase Pool H:Z4 serum, 3 mL 40366
FDA UDI
Class IIActive
Pneumococcus Group 6 serum, 1 mL 16900
FDA UDI
Class IActive
E. coli reference strain O42 81880
FDA UDI
Class IActive
E. coli O11 serum, 1 mL 85007
FDA UDI
Class IActive
E. coli O118 serum high titer, 1 mL 81532
FDA UDI
Class IActive
S. pneumoniae reference strain 6C 82182
FDA UDI
Class IActive
E. coli O102 serum high titer, 1 mL 81518
FDA UDI
Class IActive
E. coli O148 serum high titer, 1 mL 81447
FDA UDI
Class IActive
Pneumococcus Type 2 serum, 1 mL 16745
FDA UDI
Class IActive
E. coli O116 serum, 1 mL 85113
FDA UDI
Class IActive
E. coli O27 serum, 1 mL 85024
FDA UDI
Class IActive
E. coli O98 serum, 1 mL 85092
FDA UDI
Class IActive
E. coli reference strain O11 81844
FDA UDI
Class IActive
Pneumococcus Factor 12b serum high titer, 1 mL 96839
FDA UDI
Class IUnknown
Pneumococcus Factor 9g serum high titer, 1 mL 81420
FDA UDI
Class IActive
S. Enteritidis reference strain 82154
FDA UDI
Class IIActive
Salmonella monoclonal Vi serum, 3 mL 15514
FDA UDI
Class IIActive
E. coli reference strain H17 81939
FDA UDI
Class IActive
E. coli reference strain K31 81977
FDA UDI
Class IActive
Salmonella Gruppe O:50 serum, 3 mL 40248
FDA UDI
Class IIActive
E. coli O175 serum, 1 mL 85171
FDA UDI
Class IActive
Pneumococcus Factor 22b serum high titer, 1 mL 76925
FDA UDI
Class IActive
E. coli O132 serum high titer, 1 mL 81539
FDA UDI
Class IActive
E. coli reference strain O15 81848
FDA UDI
Class IActive
S. pneumoniae reference strain 41A 82257
FDA UDI
Class IActive
E. coli O7 serum high titer, 1 mL 81366
FDA UDI
Class IActive
E. coli reference strain K84 82004
FDA UDI
Class IActive
Salmonella Group O:66 serum, 3 mL 40265
FDA UDI
Class IIActive
ImmuLex S. pneumoniae Type 3, 1.5 mL 77324
FDA UDI
Class IActive
Streptococcus reference strain group B type Ia 84902
FDA UDI
Class IActive
Salmonella Gruppe O:48 serum, 3 mL 40247
FDA UDI
Class IIActive
Salmonella Gruppe O:39 serum, 3 mL 40238
FDA UDI
Class IIActive
E. coli reference strain H51 81958
FDA UDI
Class IActive
Pneumococcus Group 24 serum high titer, 1 mL 96727
FDA UDI
Class IActive
Salm. Phase Inversion SG 2 serum, 3 mL 40364
FDA UDI
Class IIActive
E. coli O28ac serum high titer, 1 mL 81418
FDA UDI
Class IActive
E. coli reference strain K44 81990
FDA UDI
Class IActive
E. coli reference strain H47 81955
FDA UDI
Class IActive
Salmonella H Phase Pool H:E serum, 1 mL 73538
FDA UDI
Class IIActive
Salmonella Phase H:f, g serum, 3 mL 53826
FDA UDI
Class IIUnknown

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