← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 1 of 29
DeviceModel / ReferenceRegistriesClassStatus
Pneumococcus Group 11 serum, 1 mL 16905
FDA UDI
Class IActive
E. coli reference strain O56 82037
FDA UDI
Class IActive
E. coli reference strain O102 82108
FDA UDI
Class IActive
E. coli H3 serum, 5 mL 54400
FDA UDI
Class IActive
Pneumococcus Group 41 serum, 1 mL 16920
FDA UDI
Class IActive
E. coli H15 serum, 5 mL 54417
FDA UDI
Class IActive
Pneumococcus Pool B serum, 1 mL 16728
FDA UDI
Class IActive
Salm. Phase Inversion H:i serum, 3 mL 86865
FDA UDI
Class IIActive
Salmonella Phase H:z44 serum, 3 mL 40316
FDA UDI
Class IIActive
E. coli O103 serum, 1 mL 85097
FDA UDI
Class IUnknown
E. coli O149 serum high titer, 1mL 81599
FDA UDI
Class IActive
Pneumococcus Factor 19b serum high titer, 1 mL 99034
FDA UDI
Class IUnknown
E. coli reference strain F4ab 85333
FDA UDI
Class IActive
Pneumococcus Group 18 serum high titer, 1 mL 76915
FDA UDI
Class IActive
E. coli O140 serum high titer, 1 mL 81595
FDA UDI
Class IActive
E. coli reference strain H2 85337
FDA UDI
Class IActive
Pneumococcus Factor 9d serum high titer, 1 mL 99021
FDA UDI
Class IActive
Salmonella Gruppe O:58 serum, 3 mL 40257
FDA UDI
Class IIActive
E. coli reference strain O22 81858
FDA UDI
Class IActive
S. pneumoniae reference strain 6B 82181
FDA UDI
Class IActive
Salm. Phase Inversion H:z71 serum, 3 mL 40400
FDA UDI
Class IIUnknown
E. coli reference strain H8 81937
FDA UDI
Class IActive
E. coli reference strain O58 82040
FDA UDI
Class IActive
S. pneumoniae reference strain 21 82223
FDA UDI
Class IActive
ImmuLex Pneumococcus Factor 6d, 1.5 mL 96976
FDA UDI
Class IActive
E. coli O10 serum, 1 mL 85006
FDA UDI
Class IActive
E. coli O170 serum high titer, 1 mL 81620
FDA UDI
Class IActive
Pneumococcus Factor 23c serum, 1 mL 16969
FDA UDI
Class IActive
E. coli reference strain O44 81883
FDA UDI
Class IActive
ImmuLex Pneumococcus Factor 18f, 1.5 mL 77339
FDA UDI
Class IActive
E. coli H20 serum, 5 mL 54425
FDA UDI
Class IActive
Pneumococcus Pool H serum, 1 mL 16736
FDA UDI
Class IActive
Salm. Phase Inversion H:z64 serum, 3 mL 40398
FDA UDI
Class IIActive
E. coli reference strain O129 82140
FDA UDI
Class IActive
E. coli OK O119 serum, 3 mL 44301
FDA UDI
Class IActive
Salmonella Factor O:7 serum, 3 mL 40274
FDA UDI
Class IIActive
E. coli O181 serum, 1 mL 85177
FDA UDI
Class IActive
E. coli reference strain H27 81946
FDA UDI
Class IActive
ImmuLex Streptococcus Group A, 1.5 mL 73258
FDA UDI
Class IUnknown
E. coli reference strain H38 85354
FDA UDI
Class IActive
S. pneumoniae reference strain 40 82255
FDA UDI
Class IActive
E. coli O11 serum high titer, 1 mL 81372
FDA UDI
Class IActive
Pneumococcus Factor 9d serum, 1 mL 16935
FDA UDI
Class IActive
E. coli reference strain O96 82102
FDA UDI
Class IActive
Salmonella Phase H:y serum, 3 mL 40305
FDA UDI
Class IIActive
E. coli O71 serum high titer, 1 mL 81475
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool C serum, 1.5 mL 52392
FDA UDI
Class IActive
E. coli H34 serum, 5 mL 54444
FDA UDI
Class IActive
ImmuLex Pneumococcus Pool T serum, 1.5 mL 52403
FDA UDI
Class IActive
E. coli reference strain H46 81954
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.