Question 1

What types of medical devices does Ssi Diagnostica A/S manufacture?

Accepted Answer

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.

Question 2

Where is Ssi Diagnostica A/S based?

Accepted Answer

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.

Question 3

Which regulatory registries list Ssi Diagnostica A/S’s devices?

Accepted Answer

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.

Question 4

How are Ssi Diagnostica A/S’s devices classified by regulatory authorities?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
E. coli reference strain K6	81964	FDA UDI	Class I	Active
Pneumococcus Factor 32b serum, 1 mL	16980	FDA UDI	Class I	Active
E. coli reference strain O12	81845	FDA UDI	Class I	Active
Salmonella H Phase Pool HMF serum, 1 mL	73535	FDA UDI	Class II	Active
Streptococcus reference strain group B type V	84907	FDA UDI	Class I	Active
Pneumococcus Factor 47a serum, 1 mL	16998	FDA UDI	Class I	Active
E. coli O55 serum, 3 mL	45794	FDA UDI	Class I	Unknown
Pneumococcus Group 17 serum high titer, 1 mL	76914	FDA UDI	Class I	Active
ImmuLex Pneumococcus Factor 6c, 1.5 mL	77335	FDA UDI	Class I	Active
E. coli reference strain O7	81840	FDA UDI	Class I	Active
E. coli O88 serum, 1 mL	85083	FDA UDI	Class I	Unknown
E. coli reference strain K40	81986	FDA UDI	Class I	Active
Pseudomonas-CF-IgG antigen pool, lyophilized	60899	FDA UDI	Class II	Unknown
E. coli O5 serum, 1 mL	85001	FDA UDI	Class I	Active
E. coli reference strain K8	85366	FDA UDI	Class I	Active
E. coli O103 serum, 3 mL	45839	FDA UDI	Class I	Active
E. coli O2 serum, 1 mL	84998	FDA UDI	Class I	Active
Pneumococcus Pool F serum, 1 mL	16734	FDA UDI	Class I	Active
Pneumococcus Factor 7b serum, 1 mL	16925	FDA UDI	Class I	Active
Salmonella Phase H:g, p serum, 3 mL	40302	FDA UDI	Class II	Unknown
E. coli reference strain O4	81835	FDA UDI	Class I	Active
Pneumococcus Factor 6d serum, 1 mL	73266	FDA UDI	Class I	Active
Salmonella Phase H:Rj serum, 3 mL	40352	FDA UDI	Class II	Active
Salmonella Phase H:Rz74 serum, 3 mL	40610	FDA UDI	Class II	Active
E. coli reference strain O118	82127	FDA UDI	Class I	Active
E. coli O25 serum, 1 mL	85022	FDA UDI	Class I	Active

Ssi Diagnostica A/S

What Ssi Diagnostica A/S makes

Frequently asked questions

Information

Catalogue (1426)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities