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ELITechGroup Announces Regulatory Approval of its Blood Borne Virus Panel in Japan

ELITechGroup’s blood-borne virus (BBV) panel received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) The ELITe BBV panel was launched in 2022 and comprises three quantitative IVD assays targeting Human Immunodeficiency virus-1 (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV) Turin, June 13, 2024: ELITechGroup…
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ELITechGroup achieves a new CE-IVDR Certification

ELITechGroup continues to expand its portfolio of IVDR-certified PCR assays to support European diagnostic laboratories The newly obtained IVDR certificate will expedite the transition to IVDR for quantitative Class C infectious diseases assays The company is fully committed to delivering its entire portfolio of nearly 60 molecular assays as IVDR…
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ELITechGroup Launches Second IVDR Certified Gastrointestinal Infection Assay: GI Parasitic PLUS ELITe MGB® Kit 

ELITechGroup launches their second kit of the Gastrointestinal infection assay panel targeting parasitic pathogens.  The ELITe MGB Gastrointestinal assays are IVDR-certified in combination with InGenius and BeGenius, fully automated samples-to-results instruments.  The company will shortly launch two more gastrointestinal assay infection panels targeting viral pathogens and Norovirus.   ELITechGroup announces the…
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ELITechGroup launches CE-IVDR certified GI Bacterial PLUS ELITe MGB® Kit and expands in vitro diagnostic portfolio

ELITechGroup launches their first kit of the Gastrointestinal assay panel targeting bacterial pathogens. ELITechGroup is planning to launch three additional kits covering the full range of gastrointestinal infections within the next quarter. In a significant move towards advancing global diagnostic capabilities, ELITechGroup proudly announces the introduction of the GI Bacterial…
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Redesigned enterovirus and parechovirus real-time PCR reagents

Enterovirus and parechovirus real-time PCR reagents Redesigned for PCR efficiency and biplex compatibility Bothell, WA, November 7, 2023 — ELITechGroup MDx LLC (EGMDx) announced availability of their redesigned enterovirus and parechovirus analyte specific reagents* (ASR). The ASRs are designed to be used in the development of real-time PCR assays and…
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ELITechGroup obtains new IVDR certificate for PCR assays

After the release of the first IVDR certificate at the beginning of the year ELITech Group continues to expand its portfolio of IVDR-certified PCR assays to support European diagnostic laboratories. The company is fully committed to delivering its entire portfolio of nearly 60 molecular assays as IVDR compliant by 2026…
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