Sensititre AIM™
GUDID 05032384497409
The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. It is designed to deliver, through a disposable dosing head, multiples of 50 µL inoculum to a Sensititre 96-well microtitration plate for in vitro antimicrobial susceptibility testing and/or identification of pathogenic microorganisms. Sensititre AIM is for professional use only and is not intended for self-testing.The performance of Sensititre AIM to inoculate standard 96-well microtitration plates (non-Sensititre plates) has not been established. Although other brands of 96-well microtitration plates may be used on the AIM instrument, they must be pre-qualified before use.
TREK DIAGNOSTIC SYSTEMS LIMITED
Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD| Primary Device ID | 05032384497409 |
| NIH Device Record Key | 6249dd0d-6772-49e2-aaa8-894649a9bafc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sensititre AIM™ |
| Version Model Number | V3020 |
| Company DUNS | 298203498 |
| Company Name | TREK DIAGNOSTIC SYSTEMS LIMITED |
| 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 | true |
| 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 | 05032384497409 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103456
FDA Product Code
| LIE | Reagent/Device, Inoculum Calibration |
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 | 2023-10-02 |
| Device Publish Date | 2023-09-22 |
Devices Manufactured by TREK DIAGNOSTIC SYSTEMS LIMITED
| 05032384571819 - Sensititre | 2024-03-14 |
| 05032384474509 - Sensititre™ Vizion™ | 2023-10-02 Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWI |
| 05032384474530 - Sensititre™ OptiRead™ | 2023-10-02 The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The |
| 05032384497409 - Sensititre AIM™ | 2023-10-02The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. It is designed to deliver, through a disposable dosing head, multiples of 50 µL inoculum to a Sensititre 96-well microtitration plate for in vitro antimicrobial susceptibility testing and/or identification of pathogenic microorganisms. Sensititre AIM is for professional use only and is not intended for self-testing.The performance of Sensititre AIM to inoculate standard 96-well microtitration plates (non-Sensititre plates) has not been established. Although other brands of 96-well microtitration plates may be used on the AIM instrument, they must be pre-qualified before use. |
| 05032384497409 - Sensititre AIM™ | 2023-10-02 The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. I |
| M578V4000 - Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST | 2022-09-16 The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobia |
Trademark Results [Sensititre AIM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSITITRE AIM 85104018 4077786 Dead/Cancelled |
TREK DIAGNOSTIC SYSTEMS LLC 2010-08-10 |
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