Opgen, Inc.

Address:9717 Key West Avenue. Suite 100,Rockville,MD,20850,US

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- Catalog Number : CP3230

Device Description : Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP3445

Device Description : PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay P PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consisting of two (2) PCR Plate Seals pouched in a labeled clear plastic bag.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP3233

Device Description : Assay Control is used to monitor extraction efficiency and PCR inhibition in the Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP3402

Device Description : Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : KT03U01-1

Device Description : PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : KT03U01-2

Device Description : A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) v A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1

- Catalog Number : AC042

Device Description : QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY, OOI

Prescription Use : Yes

Device Count : 1

- Catalog Number : AC043

Device Description : QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.

Device Class : 1

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY, JJH

Prescription Use : Yes

Device Count : 1

- Catalog Number : CP3511

Device Description : Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.

Device Class : 2

Duns Number: 119234263

Premarket Exempt : No

Product Code : PMY

Prescription Use : Yes

Device Count : 1