SSI Diagnostica


SSI Diagnostica specializes in microbiology and diagnostic solutions, offering a wide range of products including culture media, biological indicators, bacterial strains, antigens, and pneumococcal products. They serve vaccine manufacturers, veterinarians, and various application areas with a focus on high-quality, reliable testing and diagnostics. The company emphasizes scientific support, high-quality reagents, and simple, effective solutions to meet the needs of microbiology professionals worldwide. They also provide extensive documentation and certificates for their products, including detailed Certificates of Analysis (COA) for various culture media and diagnostic products, ensuring compliance and quality assurance.

Industries

medical-device

Nr. of Employees

medium (51-250)

SSI Diagnostica


Patents

Compositions and means for diagnosing microbial infections

US-8753875-B2

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Products

Serotype‑specific polyclonal antisera (ready‑to‑use)

Ready‑to‑use polyclonal antisera produced and characterized for serotype identification and vaccine quality control applications.

Purified capsular polysaccharides (lyophilized vials)

Individually purified capsular polysaccharides supplied as lyophilized vials with specified residual cell‑wall polysaccharide levels for use as assay reagents or antigen starting material.

Cell‑wall polysaccharide adsorption preparations

CWPS preparations (single‑variant and mixed) intended for adsorption steps in immunoassays to reduce nonspecific binding and cross‑reactivity.

Characterized bacterial strain panels for in vitro testing

Documented bacterial strains provided for laboratory serotyping and in vitro testing, with specified intended use limitations.

Biological sterilization indicators (spore‑based)

Spore‑based biological indicators packaged for periodic validation of dry‑heat and autoclave sterilization cycles, with defined spore loads per unit.

Chemical sterilization indicators and cleaning simulators

Chemical indicators for steam and dry‑heat sterilization and patient‑care/device‑cleaning (PCD) simulators for instrument washer validation and cleaning process monitoring.

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Services

Made‑to‑order production of serotype‑targeted polyclonal antisera generated by animal immunization and characterized for use in serotyping and vaccine quality control.

Periodic shipment service providing biological and chemical sterilization indicators and cleaning/PCD simulators on a scheduled subscription with invoicing at shipment.

Web‑accessible repository of lot‑specific Certificates of Analysis for culture media and reagents, including downloadable PDF COAs and archived older versions for traceability and regulatory review.

Scientific support for selection and use of reagents, assay configuration and interpretation of serological validation results related to vaccine quality control and diagnostic reagents.

Web‑accessible listing and downloadable Certificates of Analysis for biological sterilization indicators and related chemical indicators, including current and archived COA documents for sterilization products.

Expertise Areas

  • Reagent and antigen manufacturing for vaccine quality control
  • Polyclonal antisera production and serological characterization
  • Capsular polysaccharide purification and lyophilization
  • Serological assay development and validation (quellung/Neufeld, immunochemistry, ELISA)
  • Show More (6)

Key Technologies

  • Polyclonal antisera generation (animal immunization)
  • Capsular polysaccharide purification and lyophilization
  • Cell‑wall polysaccharide adsorption preparations
  • Serotyping by quellung/Neufeld methodology
  • Show More (6)

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