Diagnostics Product Guide » Bacterial Testing

Seegene New MagicplexTM Sepsis Test Indentifies Over 90 Indicators for Deadly In-Hospital Disease

admin — Wed, 21 Jul 2010 08:49:01 +0000

Seegene has announced the availability of Magicplex™ Sepsis, a new multi-pathogen screening test capable of quick and accurate identification of over 90 leading sepsis-causing pathogens. Magicplex Sepsis provides a novel and fast-acting diagnostic technique for hospitals to simultaneously verify a complex range of targets that indicate sepsis, the leading cause of death in non-coronary intensive care units worldwide. Magicplex Sepsis Test will not be available in the USA until regulatory clearance.

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Abbott Receives 510(k) Clearance For CT/NG Assay And Abbott m2000 System

admin — Thu, 08 Jul 2010 21:01:55 +0000

Abbott has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation’s most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden. Abbott received independent 510(k) clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System.

Roche Gets FDA Ok For LightCycle Test

admin — Thu, 08 Jul 2010 20:57:24 +0000

Roche Molecular Systems Inc announced that the FDA has cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States. The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA. The test is designed to aid in the prevention and control of MRSA infections in healthcare settings.

Cepheida receives approval for its bacterial diagnostic test

admin — Tue, 14 Jul 2009 04:19:36 +0000

Molecular-diagnostic company Cepheid has received the Food and Drug Administration (FDA) approval for a test that helps in rapid diagnosis of a bacteria linked to antibiotic-resistant infections. Cepheid’s Xpert C.difficile test can detect within 45 minutes a bacterium that causes the Clostridium difficile infection, resulting in diarrhea and more serious intestinal conditions, such as colitis.

MDS Analytical Technologies makes available a new method for melanin detection in food

admin — Mon, 17 Nov 2008 13:14:18 +0000

MDS Analytical Technologies has announced that the Abraxis Melamine Detection Kit has been validated for use on company’s SpectraMax(R) absorbance microplate readers with SoftMax(R) Pro 5 GxP analytical software. The product offers a cost-effective, high-throughput, quality-assurance solution to detect melamine contamination in such food products as milk, infant formula, pet food, and confectionery. This solution further enables the company to expand its offering in applied markets. MDS Analytical Technologies also offers a mass spectrometry-based solution for food safety testing.

Thermo Fisher receives US market clearance for MRSA test

admin — Mon, 07 Apr 2008 23:33:36 +0000

A test to screen patients for MRSA, or methicillin-resistant Staphylococcus aureus, developed by Thermo Fisher Scientific Inc., has been granted U.S. market clearance. MRSA, also known as superbug, is a deadly bacteria that has been increasing its prevalence in America and is a cause for concern due to its resistance to common antibiotics.