Acuitas 62005
GUDID 04260364751000
QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Curetis GmbH
Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD| Primary Device ID | 04260364751000 |
| NIH Device Record Key | e1bc11bd-1fcb-47cd-a4b4-d3d814cc5f49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuitas |
| Version Model Number | QIAGEN® EZ1® Advanced XL System |
| Catalog Number | 62005 |
| Company DUNS | 312621863 |
| Company Name | Curetis GmbH |
| 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 | 01812125010074 [Previous] |
| GS1 | 04260364751000 [Primary] |
| GS1 | 20812125010079 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191288
FDA Product Code
| OOI | Real Time Nucleic Acid Amplification System |
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 | 2023-04-25 |
| Device Publish Date | 2023-04-17 |
On-Brand Devices [Acuitas]
| 04260364751031 | Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master |
| 04260364751024 | PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay P |
| 04260364751017 | QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel. |
| 04260364751000 | QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel. |
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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