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FDA grants 510(k) approval for BioPlex 2200 Syphilis Total & RPR assay to diagnosis syphilis infection. Bio-Rad Laboratories

Read time: 1 mins
Last updated:15th Jun 2017
Published:15th Jun 2017
Source: Pharmawand

Bio-Rad Laboratories, Inc., a global provider of life science research and clinical diagnostic products, announced it has received FDA 510(k) clearance for its BioPlex 2200 Syphilis Total & RPR assay, a novel one-step universal testing method to aid in the diagnosis of syphilis infection.

The release of the BioPlex 2200 Syphilis Total & RPR assay is the latest offering in Bio-Rad�s growing infectious disease menu for the BioPlex 2200 System, a fully automated multiplex technology platform. The BioPlex 2200 System provides clinical laboratories the capability to rapidly process or �multiplex� multiple individual tests that are traditionally processed separately, conserving patient sample volume and simplifying workflow.

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