BC Week In Review | Jun 15, 2015
Clinical News

DPP HIV 1/2 Assay regulatory update

Chembio received CE Mark approval for DPP HIV 1/2 Assay to detect HIV infection. Chembio plans to launch the immunochromatographic rapid screening assay in Europe in 4Q15. The test is based on the company’s Dual...
BC Week In Review | Jun 16, 2014
Company News

Chembio sales and marketing update

Chembio launched its DPP HIV 1/2 Assay and corresponding DPP HIV 1/2 Control Pack in the U.S. for HIV detection. The assay is an immunochromatographic, rapid screening assay based on the company's Dual Path Platform...
BC Week In Review | Feb 17, 2014
Clinical News

DPP HIV 1/2 Assay regulatory update

Chembio said it now expects a delay on a CLIA waiver application under review by FDA for its DPP HIV 1/2 Assay as an aid in diagnosing HIV/AIDS infection in patients >=2 years. The company,...
BC Week In Review | Dec 9, 2013
Clinical News

DPP HIV 1/2 Assay regulatory update

Chembio submitted a CLIA waiver application to FDA for its DPP HIV 1/2 Assay as an aid in diagnosing HIV/AIDS infection in patients >=2 years. The company hopes to launch the product in 2Q14. FDA...
BC Week In Review | Jan 7, 2013
Clinical News

DPP HIV 1/2 Assay regulatory update

On Dec. 21, 2012, Chembio said FDA approved a PMA for DPP HIV 1/2 Assay as an aid in diagnosing HIV/AIDS infection in patients >=2 years. Chembio plans to submit a CLIA waiver for the...
BC Week In Review | Jun 18, 2012
Clinical News

DPP HIV 1/2 Screen regulatory update

Chembio submitted to FDA the third and final module of a PMA for its DPP HIV 1/2 Screen as an aid in diagnosing HIV/AIDS infection. The company expects a decision from FDA by year end....
BC Week In Review | Apr 23, 2012
Clinical News

DPP HIV 1/2 Screen: Completed pivotal trial enrollment

Chembio completed enrollment of about 3,000 patients in a U.S. pivotal trial evaluating its DPP HIV 1/2 Screen. The trial supports the third and final module of Chembio's PMA to FDA. Chembio expects to submit...
BC Week In Review | Apr 25, 2011
Clinical News

DPP HIV 1/2 Screen regulatory update

Chembio submitted to FDA the first module of a PMA for its DPP HIV 1/2 Screen as an aid in diagnosing HIV/AIDS infection. The company plans to submit the final 2 modules in 3Q11 and...
BC Week In Review | Oct 4, 2010
Clinical News

DPP HIV 1/2 Confirmatory rapid test regulatory update

The Oswaldo Cruz Foundation (Rio de Janeiro, Brazil) received marketing approval in Brazil for Chembio's DPP HIV 1/2 Confirmatory rapid test to detect HIV-1 and HIV-2 antibodies in whole blood, serum or plasma samples. The...
BC Week In Review | Jul 5, 2010
Clinical News

DPP Oral HIV 1/2 screen assay regulatory update

The Oswaldo Cruz Foundation (Rio de Janeiro, Brazil) received marketing approval in Brazil for Chembio's DPP HIV 1/2 rapid test to detect HIV 1/2 antibodies in oral fluid, blood, serum or plasma samples. The marketing...
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