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Tag Archives: Alere—

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. ...

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FDA clears Alere i Influenza A & B 2 test

Oct. 9, 2017—Alere announced that its Alere i Influenza A & B 2 test has received 510(k) marketing clearance from the FDA for the detection of influenza A and B infection in children and adults. Alere i Influenza A & B 2 is a second-generation rapid molecular assay that can report a positive result in as few as five minutes. ...

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Siemens buys Epocal from Alere

July 26, 2017—Siemens Healthineers has entered into a definitive agreement to acquire Epocal, a subsidiary of Alere. Epocal develops and provides point-of-care blood diagnostic systems for health care enterprises, including the Epoc Blood Analysis System, a handheld, wireless testing solution. The transaction is subject to the completion of Abbott’s acquisition of Alere, as well as antitrust approvals and other customary ...

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FDA clearance for Alere Reader platform, 6/17

June 2017—Alere announced that its Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats and that can be used in point-of-care and laboratory settings, received FDA 510(k) clearance.

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Alere Reader platform FDA cleared

April 27, 2017—Alere announced the introduction of its Alere Reader, an FDA 510(k)-cleared diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats. The Alere Reader, which can be used in point-of-care and laboratory settings, will be initially available for use with the BinaxNow Influenza A & B ...

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IVD CE mark for lateral flow assay analyzer, 11/16

November 2016—Alere announced it has achieved in vitro diagnostic CE marking in Europe for its Alere Reader, a diagnostic analyzer that can be used in point-of-care and laboratory settings. The Alere Reader will be available initially for use with the Alere BinNow Legionella and Streptococcus pneumonia antigen cards, with other lateral flow applications and assays to follow.

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Alere’s rapid RSV POC test cleared

Sept. 8, 2016—Alere announced that its point-of-care RSV test has received 510(k) marketing clearance from the Food and Drug Administration for the detection of respiratory syncytial virus infection in children and adults. Following tests for streptococcus A and influenza A and B, the RSV test is the latest offering on the Alere i platform and is the first molecular test ...

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Chembio ends Alere distribution agreement

Feb. 10, 2016—Chembio Diagnostics will begin selling its Sure Check HIV 1/2 Assay in the U.S. market on June 1, 2016. The product is currently distributed in the U.S. by Alere under Alere’s Clearview Complete brand, and Chembio has notified Alere that it will not renew or extend the distribution agreement when it terminates May 31, 2016. The Sure Check ...

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HIV point-of-care test, 9/13:103

Alere has received FDA approval to market its Alere Determine HIV-1/2 Ag/Ab Combo in the United States. The Alere Determine HIV-1/2 Ag/Ab Combo is a rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.

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