CE mark: Page 5

PathogenDx nabs CE-IVD Mark for DetectX-Rv test
By LabPulse.com staff writers
DetectX-Rv will now be available for sale and distribution to qualified laboratories across the European Union. DetectX-Rv's microarray utilizes nasopharyngeal swabs and nasal aspirate or fluid to detect SARS-CoV-2 within three hours after RNA extraction.
July 21, 2021
2021 02 25 23 48 3444 Covid Virus Dna Molecule 400
Hologic gets CE Mark for COVID-19 test
By LabPulse.com staff writers
The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19 and runs on the fully automated Panther system, Hologic said.
July 14, 2021
2019 02 01 17 54 2200 Hologic Rsna 2018 400
Seegene unveils SARS-CoV-2 variant detection test
By LabPulse.com staff writers
The kit, which received the CE-IVD Mark in June, can identify key genetic variants such as L452R, W152C, K417T, and K417N, according to the South Korean firm. It can also detect in a single reaction six COVID-19 variants: Delta, Delta Plus, and Kappa (first detected in India); Gamma (first detected in Brazil); Beta (first detected in South Africa); and Epsilon (first detected in California), the company said.
July 12, 2021
2021 07 13 19 48 5862 Sars Co V 2 Ace2 Binding 400
Quidel secures CE Mark for Savanna molecular analyzer, assay
By LabPulse.com staff writers
Savanna allows users to analyze 12 pathogens in a single test that lasts less than 30 minutes, according to Quidel. Its Savanna RVP4 Assay is a nucleic acid test to detect influenza, respiratory syncytial virus, and SARS-CoV-2, the company said.
July 11, 2021
2020 04 14 17 10 6379 Test Tubes Rd Lab 400
Inova's Aptiva autoimmune disease assay gets FDA nod
By LabPulse.com staff writers
The company's Aptiva system and Aptiva Celiac Disease Immunoglobulin A (IgA) assay are based on Inova's particle-based multianalyte technology (PMAT). This technology allows Aptiva to deliver up to 720 results per hour using a 12-analyte test cartridge, allowing a laboratory to complete its workflow in a single shift, according to the San Diego-based company.
June 29, 2021
2021 06 30 21 55 5977 2021 06 29 Inova Aptiva 400
FDA grants EUA for Diabetomics' SARS-CoV-2 Ab test
By LabPulse.com staff writers
The CovAb test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless, the company said in a statement. The test is CLIA-waived, is all-inclusive, and does not require any additional components or instrumentation, Diabetomics said. Test results reportedly are available within 15 minutes.
June 23, 2021
2020 01 21 22 13 2411 Virus Coronavirus 400
Hologic receives CE Mark for CMV detection assay
By LabPulse.com staff writers
The Aptima CMV Quant assay quantifies the viral load of CMV and is intended for use in aiding in diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients.
June 22, 2021
2019 05 13 16 12 9218 Lab Blood Woman2 400
Epredia, Aiforia ink distribution agreement
By LabPulse.com staff writers
Epredia will distribute Aiforia's Ki67 AI model, which has the CE-IVD Mark, for breast cancer diagnostics in Denmark, France, Germany, Iceland, Italy, Japan, Norway, Spain, Sweden, and the U.S. The software will be part of Epredia's digital pathology portfolio, which already includes its 3DHistech P1000 WSI scanner, the company said.
June 20, 2021
2021 06 21 19 08 4301 Clinical Ki67 Ia 400
Co-Diagnostics secures CE Mark for direct saliva SARS-CoV-2 test
By LabPulse.com staff writers
The test identifies the presence of the RdRp and E genes of SARS-CoV-2 from human saliva samples and eliminates the RNA extraction process, making it less costly and time-consuming, according to the firm.
June 20, 2021
2020 06 15 18 14 5259 Swab Sample Collection 400
Promega SARS-CoV-2 antibody test gets CE Mark
By LabPulse.com staff writers
The assay is a qualitative IVD test that detects antibodies against the receptor-binding domain antigen within the SARS-CoV-2 spike in serum in less than one hour at room temperature.
June 8, 2021
2019 09 16 18 27 8672 Quality Check Mark 400
Ibex obtains CE Mark for Galen Breast software
By LabPulse.com staff writers
Galen Breast uses artificial intelligence (AI) and machine learning and was trained on hundreds of thousands of image samples, scanned from biopsy slides digitized using digital pathology, according to the company.
May 25, 2021
2019 04 15 22 17 2307 Breast Cancer 400
SpeeDx secures European CE-IVD Mark for COVID-19 test
By LabPulse.com staff writers
PlexPCR has been tested with a database of more than 1 million sequences, according to the firm. It is compatible with the company's PlexPCR RespiVirus test as well as its PlexPrep liquid handling system and works with 96- or 384-well quantitative polymerase chain reaction (qPCR) systems and liquid handling robotics.
April 26, 2021
2021 04 27 23 07 7463 Sars Co V 2 Particles Sem Niaid 400
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