No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812125010051 | CP3402 | CP3402 | 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. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
2 | 00812125010044 | CP3233 | CP3233 | 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. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
3 | 00812125010020 | CP3445 | CP3445 | 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. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
4 | 00812125010013 | CP3230 | CP3230 | 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. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
5 | 01812125010081 | CP3511 | CP3511 | Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
6 | 01812125010074 | AC043 | AC043 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. | PMY,JJH | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony,Clinical Sample Concentrator | 1 | Acuitas |
7 | 01812125010067 | AC042 | AC042 | 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. | PMY,OOI | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony,Real Time Nucleic Acid Amplification System | 2 | Acuitas |
8 | 01812125010005 | KT03U01-1 | KT03U01-1 | 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. | PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Ne System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | Acuitas |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 01812125010081 | CP3511 | CP3511 | Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software. | Acuitas | OPGEN, INC. |
2 | 01812125010074 | AC043 | AC043 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. | Acuitas | OPGEN, INC. |
3 | 01812125010067 | AC042 | AC042 | 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. | Acuitas | OPGEN, INC. |
4 | 01812125010036 | KT03U01-2 | KT03U01-2 | 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. | Acuitas | OPGEN, INC. |
5 | 01812125010005 | KT03U01-1 | KT03U01-1 | 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. | Acuitas | OPGEN, INC. |
6 | 00840733102370 | 410500 | 410500 | The revogene Carba assay performed on the revogene instrument is a qualitative i The revogene Carba assay performed on the revogene instrument is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. | Revogene Carba C | MERIDIAN BIOSCIENCE, INC. |
7 | 00812125010051 | CP3402 | CP3402 | 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. | Acuitas | OPGEN, INC. |
8 | 00812125010044 | CP3233 | CP3233 | 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. | Acuitas | OPGEN, INC. |
9 | 00812125010020 | CP3445 | CP3445 | 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. | Acuitas | OPGEN, INC. |
10 | 00812125010013 | CP3230 | CP3230 | 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. | Acuitas | OPGEN, INC. |
11 | 00628055344162 | 410500 | 410500 | The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. | Revogene® Carba C | MERIDIAN BIOSCIENCE CANADA INC |
12 | 00628055344070 | 133499 | 133499 | The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. | GenePOC™ Carba | GENEPOC INC |
13 | 07332940001032 | GXCARBAR-10 | GXCARBAR-10 | Xpert Carba-R test; 10 test kit | Xpert Carba-R | CEPHEID |