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Tag Archives: Bio-Rad—

Bio-Rad quality controls, 9/17

September 2017—Bio-Rad Laboratories has added four analytes to the company’s Liquichek Tumor Marker Control. The updated control received FDA 510(k) clearance and the CE mark and is available for the immunoassay-based tumor marker testing market.

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Quality controls, critical raw materials, 10/16

October 2016—Bio-Rad Laboratories launched Amplichek II quality control, which was issued a de novo clearance from the FDA. Amplichek II is the first in a series of infectious disease controls that the company is introducing to the molecular diagnostic testing market. It is an independent, multianalyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of health care–associated infections.

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Maternal serum control, 7/16

July 2016—Bio-Rad Laboratories released its Liquichek Maternal Serum II Control, a frozen liquid human serum-based material designed to monitor the precision of laboratory test procedures used during maternal serum second trimester screening.

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CE IVD mark for digital PCR system, 5/16

May 2016—Bio-Rad Laboratories announced CE IVD marking for its QX200 Droplet Digital PCR System. The technology, which partitions a DNA or RNA sample into 20,000 droplets and amplifies targeted sequences within each droplet, allows scientists to precisely detect and quantify low concentrations of target DNA and RNA sequences.

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Bio-Rad, Illumina partnership, 3/16

March 2016—Bio-Rad Laboratories and Illumina announced an exclusive partnership to develop a comprehensive next-generation sequencing workflow for single-cell analysis. The end-to-end commercial solution will enable high-throughput sequencing of thousands of individual cells.

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FDA clearance for A1c testing system, 3/16

March 2016—Bio-Rad Laboratories announced that its D-100 System for A1c testing has obtained FDA clearance to monitor the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes, and to help identify those who may be at risk for developing the disease.

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