DPC (Diagnostic Products Corporation) takes US allergy test to the US:
This article was originally published in Clinica
Executive Summary
The US FDA has granted Diagnostic Products Corporation clearance to market its third generation IgE allergy test. The 510(k) approval for Immulite 2000 Allergen-Specific IgE has prompted the Los Angeles firm to rename the product Immulite 2000 Third Generation Allergen-Specific IgE, saying it is in a separate class to previous tests in terms of analytical performance. Run on the fully automated Immulite 2000 platform the assay offers a 0.1kU/L detection limit, which is 3.5 times lower than other allergen-specific tests, according to DPC. The company said that the new assay would be cost-effective enough for use by even very small laboratories.