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The OSOM® Ultra Plus Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab and nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection.
Simple CLIA-waived procedure with pre-measured extraction buffer for swab samples
Accurate, differentiated interpretation of results in 10 minutes to test and treat patients in one office visit
Sample Type: Nasal swab and nasopharyngeal swab
Product Availability: Market authorization obtained for EU only
The OSOM® RSV/Adeno test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) and/or Adenovirus antigens directly from nasal swabs or nasal suction fluid in patients suspected of having a viral respiratory infection. Throat swabs are also an acceptable sample type for the detection of Adenovirus antigens.
Sensitivity versus PCR > 90% (RSV); 85% (Adenovirus)
Differentiates between RSV and Adenovirus
Easy-to-read 3 distinct lines
Less than 1 minute hands-on time; results in 10 minutes or less.
The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescent technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button.
Reverse Transcription Polymerase Chain Reaction (RT-PCR)-based In Vitro Diagnostic (IVD) test intended for the qualitative detection of nucleic acid belonging to SARS-CoV-2. This test is suitable for use directly from either (1) Viral Transport Media (VTM) / Universal Transport Media (UTM) containing nasopharyngeal swab specimen; OR (2) Human saliva specimen.
Both specimen types do not require viral RNA extraction prior to testing.
Compatibility • VTM* / UTM* containing nasopharyngeal swab specimen • Human saliva specimen collected using ZeroPrep™ Saliva Collection Kit (* validated with 5 different brands of VTM / UTM)
Gene Targets • Dual N1 and N2 gene targets (FAM) • Human RPP30 as Internal Control (HEX)
Time-to-Result • Approximately 90 mins
Sensitivity • 10 viral RNA copies per test (4 viral RNA copies per uL Saliva)
Specificity • No cross-reactivity with human genome / other coronaviruses / respiratory viruses
Headquartered in Burlington, MA, for over 35 years SEKISUI Diagnostics has been committed to helping improve the lives of patients by providing innovative medical diagnostics to physicians and laboratories. We have a history of innovation which includes, the first homogeneous test for LDL and the first plastic vacuum blood collection tube. We continue to invest in the areas of diabetes, infectious disease, coagulation, diagnostic enzymes and automated systems, and have a leading position as a provider of rapid tests in the US and high throughput coagulation systems in Japan.
Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan and in China, making us a worldwide company with R&D and Manufacturing facilities on three continents.
We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include:
· Clinical chemistry reagents
· Coagulation systems and reagents
· Point-of-care molecular, rapid tests and immunoassay system