RealStar SARS-CoV-2 RT-PCR Kit U.S.*

From the manufacturer

Quoted verbatim from the manufacturer’s published product page. IVDmap did not write or verify this text.

• The RealStar SARS-CoV-2 RT-PCR Kit U.S.* is authorized for a workflow consisting of nucleic acid extraction using the AltoStar Automation System AM16 in combination with the AltoStar Purification Kit 1.5 and the AltoStar Internal Control 1.5, followed by the amplification and detection of SARS-CoV-2 specific RNA using the RealStar SARS-CoV-2 RT-PCR Kit U.S.*

  altona Diagnostics GmbHCategory L2Manufacturer Page2026-10-16

• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens .

  altona Diagnostics GmbHTarget PathogensManufacturer Page2026-10-16

• For use with . CFX96 Touch Real-Time PCR Detection System . CFX96 Touch Deep Well Real-Time PCR Detection System . Please remark . This test has not been FDA-cleared or approved . This test has been authorized by FDA under an EUA for use by authorized laboratories . This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens .…

  altona Diagnostics GmbHCompatible InstrumentsManufacturer Page2026-10-16