Bio-Rad Laboratories, Inc. have entered into the rapidly growing molecular diagnostics testing market with the launch of Amplichek™ II quality control, which was recently issued a de novoclearance from the FDA.

The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping in May and is the first in a series of infectious disease controls that Bio-Rad plans to introduce for the molecular diagnostic testing market.

Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Healthcare Associated Infections (HAIs).