Acuitas AC042
GUDID 20812125010062
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
Thermal cycler nucleic acid amplification analyser IVD, laboratory| Primary Device ID | 20812125010062 |
| NIH Device Record Key | fd4de801-4706-4798-a0d3-7550d2beb36b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuitas |
| Version Model Number | AC042 |
| Catalog Number | AC042 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 20812125010062 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191288
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 | 2023-05-08 |
| Device Publish Date | 2023-04-28 |
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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