Acuitas 12001
GUDID 04260364751024
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.
Curetis GmbH
Microplate IVD| Primary Device ID | 04260364751024 |
| NIH Device Record Key | 7c1e5fbc-51b1-4d54-bc5a-f96cb665543a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuitas |
| Version Model Number | Acuitas AMR Gene Panel PCR Plate Kit |
| Catalog Number | 12001 |
| 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 | 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 [Previous] |
| GS1 | 04260364751024 [Primary] |
| GS1 | 20812125010000 [Previous] |
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 | 2023-04-25 |
| 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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