Home >> Tag Archives: Abbott—

Tag Archives: Abbott—

Abbott next-gen influenza A & B, strep A assays

Oct. 29, 2018—Abbott announced FDA clearance and CLIA waiver of its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The Influenza A & B 2 assay detects and differentiates influenza A and B virus in 13 minutes or less, with early call out of positive results in as few as five minutes. The ...

Read More »

FDA OKs Afinion HbA1c Dx to diagnose diabetes

June 26, 2018—Abbott announced the FDA has cleared the Afinion HbA1c Dx assay, a rapid point-of-care test to help diagnose diabetes mellitus and assess a patient’s risk of developing the disease, for use with the Afinion AS100 Analyzer. In analytical and clinical studies, the Afinion HbA1c assay demonstrated accurate, precise, and reliable results comparable with those of central laboratory systems (Swensen ...

Read More »

Abbott closes deal on Alere

Oct. 9, 2017—Abbott successfully completed its purchase of Alere on Oct. 3. The deal originally began in February 2016, when the companies first announced the purchase agreement. “Creating the world’s leading point-of-care business will help Abbott meet the growing demand for fast, accurate, and actionable information,” Brian Blaser, executive vice president of diagnostics products for Abbott, said in a statement. ...

Read More »

North West London Pathology inks deal with Abbott

Aug. 24, 2017—North West London Pathology, hosted by Imperial College Healthcare NHS Trust, and Abbott have signed a $252 million managed equipment services contract for the supply of all analytical equipment and consumables, including Abbott’s Alinity ci and Alinity h series diagnostics instruments as well as its professional services and informatics solutions known as AlinIQ. The contract was the subject ...

Read More »

Abbott expands launch of Sekisui CP3000

July 28, 2017—Abbott announced that the Sekisui CP3000 coagulation system, a fully automated analyzer that tests bleeding and clotting function in blood, is now available in Europe, the Middle East, and Asia Pacific. Abbott is the exclusive global distributor of the CP3000 coagulation system in the U.S., Europe, and other countries that recognize the CE mark and has nonexclusive distribution ...

Read More »

Abbott CMV molecular test OK’d by FDA

July 6, 2017—Abbott’s RealTime CMV molecular test received FDA approval and is now available in the United States. According to the company, it is the only commercially available cytomegalovirus test with the ability to amplify two select regions (dual target) of the CMV genome, which helps reduce the risk of under-quantitation or failure to detect the virus—a known concern with ...

Read More »

FDA grants Abbott EUA for molecular Zika test

Feb. 14, 2017—The FDA has authorized Abbott’s molecular RealTime Zika test to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency use. “Diagnosing a Zika infection can be challenging, especially since people might not have any symptoms or only have mild symptoms that last a few days,” John Hackett, PhD, Abbott’s divisional ...

Read More »
X