Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Acuitas

FDA UDI

Opgen, Inc.·01812125010036·A reagent kit for use with Acuitas AMR Gene Pan...

Acuitas

FDA UDI

Opgen, Inc.·00812125010013·Sealed, 96-well plate in Mylar Pouch. Each sea...

Acuitas

FDA UDI

Opgen, Inc.·10812125010027·PCR Plate Seal Package component of KT03U01-1 A...

Acuitas

FDA UDI

Opgen, Inc.·01812125010067·QuantStudio Real-Time PCR Instrument Qualified ...

Acuitas

FDA UDI

Opgen, Inc.·10812125010058·Approximately 700 µl Master Mix in 1.5 ml screw...

Acuitas

FDA UDI

Opgen, Inc.·00812125010044·Assay Control is used to monitor extraction eff...

Acuitas

FDA UDI

Opgen, Inc.·20812125010086·Labeled, OpGen branded flash drive containing I...

Acuitas

FDA UDI

Opgen, Inc.·20812125010062·QuantStudio Real-Time PCR Instrument Qualified ...

Acuitas

FDA UDI

Opgen, Inc.·20812125010031·A reagent kit for use with Acuitas AMR Gene Pan...

Acuitas

FDA UDI

Opgen, Inc.·01812125010081·Labeled, OpGen branded flash drive containing I...

Acuitas

FDA UDI

Opgen, Inc.·20812125010079·QIAGEN EZ1 Advanced XL Instrument for use with ...

Acuitas

FDA UDI

Opgen, Inc.·20812125010000·PCR Assay Plate Kit for use with Acuitas AMR Ge...

Acuitas

FDA UDI

Opgen, Inc.·00812125010051·Approximately 700 µl Master Mix in 1.5 ml screw...

Acuitas

FDA UDI

Opgen, Inc.·00812125010020·PCR Plate Seal Package component of KT03U01-1 A...

Acuitas

FDA UDI

Opgen, Inc.·01812125010074·QIAGEN EZ1 Advanced XL Instrument for use with ...

Acuitas

FDA UDI

Opgen, Inc.·01812125010005·PCR Assay Plate Kit for use with Acuitas AMR Ge...

Acuitas

FDA UDI

Opgen, Inc.·10812125010041·Assay Control is used to monitor extraction eff...

Acuitas

FDA UDI

Opgen, Inc.·10812125010010·Sealed, 96-well plate in Mylar Pouch. Each sea...

MODIFIED OLSEN 755/756 SWITCHPENS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery