Acuitas KT03U01-1
GUDID 01812125010005
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.
Opgen, Inc.
Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD| Primary Device ID | 01812125010005 |
| NIH Device Record Key | 132b0fa7-ea4e-4487-9b53-93e8b5584827 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuitas |
| Version Model Number | KT03U01-1 |
| Catalog Number | KT03U01-1 |
| Company DUNS | 119234263 |
| Company Name | Opgen, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 01812125010005 [Primary] |
FDA Product Code
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-14 |
| Device Publish Date | 2021-10-06 |
On-Brand Devices [Acuitas]
| 01812125010036 | A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Mast |
| 01812125010005 | PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay P |
| 01812125010081 | Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software. |
| 01812125010074 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. |
| 01812125010067 | QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. |
| 00812125010051 | Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 A |
| 00812125010044 | Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gen |
| 00812125010020 | PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consist |
| 00812125010013 | Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate |
| 20812125010086 | Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software. |
| 20812125010079 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. |
| 20812125010062 | QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. |
| 20812125010031 | A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Mast |
| 20812125010000 | PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay P |
| 10812125010058 | Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 A |
| 10812125010041 | Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gen |
| 10812125010027 | PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consist |
| 10812125010010 | Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate |
Trademark Results [Acuitas]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUITAS 86505245 4803312 Live/Registered |
OpGen, Inc. 2015-01-16 |
 ACUITAS 86235340 4721463 Live/Registered |
OpGen, Inc. 2014-03-28 |
 ACUITAS 85527529 not registered Dead/Abandoned |
Affirmed Networks, Inc. 2012-01-27 |
 ACUITAS 85222861 4124022 Live/Registered |
Acuitas, LLC 2011-01-21 |
 ACUITAS 85021118 3883098 Live/Registered |
IHEARTMEDIA MANAGEMENT SERVICES, INC. 2010-04-22 |
 ACUITAS 78916208 3244585 Dead/Cancelled |
Clear Channel Management Services, L.P. 2006-06-24 |
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