07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Lyra Parainfluenza Assay regulatory update

Quidel said FDA granted 510(k) clearance to the company's Lyra Parainfluenza Assay to quantitatively detect human parainfluenza virus (HPIV) infections types 1, 2 or 3 viral RNA from nasal swab and nasopharyngeal swab specimens. The...
07:00 , Oct 20, 2014 |  BC Week In Review  |  Clinical News

Lyra Adenovirus Assay regulatory update

Quidel said FDA granted 510(k) clearance to its Lyra Adenovirus Assay to qualitatively detect human adenovirus viral DNA isolated from nasal and nasopharyngeal swab specimens. The multiplex real-time PCR in vitro assay is available for...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Lyra Influenza A Subtype H7N9 Assay regulatory update

FDA granted Emergency Use Authorization (EUA) to Quidel's Lyra Influenza A Subtype H7N9 Assay for the presumptive detection of influenza A (H7N9) virus in patients with signs and symptoms of respiratory infection who have positive...
07:00 , Sep 23, 2013 |  BC Week In Review  |  Clinical News

Quidel Molecular RSV + hMPV assay regulatory update

Quidel said FDA granted 510(k) clearance for its Quidel Molecular RSV + hMPV assay for use on the QuantStudio Dx Real-Time PCR instrument from Life Technologies Corp. (NASDAQ:LIFE, Carlsbad, Calif.) to detect the presence...
07:00 , Sep 23, 2013 |  BC Week In Review  |  Clinical News

Quidel Molecular Influenza A+B Assay regulatory update

Quidel said FDA granted 510(k) clearance for its Quidel Molecular Influenza A+B assay for use on the QuantStudio Dx Real-Time PCR instrument from Life Technologies Corp. (NASDAQ:LIFE, Carlsbad, Calif.) to detect the presence of...
07:00 , Jul 22, 2013 |  BC Week In Review  |  Clinical News

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Kit regulatory update

FDA granted 510(k) clearance to Quanta's CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Kit to detect influenza A and B and determine the subtype of seasonal human influenza A viruses from respiratory specimens. The...
07:00 , May 16, 2011 |  BC Week In Review  |  Company News

Life Technologies sales and marketing update

Life Technologies launched its 7500 Fast Dx Real-Time PCR instrument and 3500 Dx Series Genetic Analyzer in Japan. The instruments have been approved as in vitro diagnostic (IVD) platforms in the territory. The 7500...
07:00 , Jul 19, 2010 |  BC Week In Review  |  Clinical News

BCR/ABL1 Quant Test regulatory update

Asuragen received CE Mark approval in Europe for its BCR/ABL1 Quant Test to aid in the assessment of complete cytogenetic response (CCyR), major molecular response (MMR), minimal residual disease and relapse in Philadelphia chromosome-positive chronic...
07:00 , Mar 29, 2010 |  BC Week In Review  |  Company News

Life Technologies sales and marketing update

Life Technologies launched its Applied Biosystems 7500 Fast Dx Real-Time PCR instrument in Europe for in vitro diagnostic use. Life Technologies Corp. (NASDAQ:LIFE), Carlsbad, Calif.   Business: Diagnostic   ...
08:00 , Mar 1, 2010 |  BC Week In Review  |  Clinical News

Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay regulatory update

FDA granted Longhorn emergency use authorization (EUA) for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR to detect 2009 H1N1 influenza virus. The PCR-based assay is designed to run on the ABI 7500 Fast Dx Real-Time...