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| 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
| 05032384571499 - Sensititre | 2025-04-21 |
| 05032384571482 - Sensititre | 2025-04-21 |
| 05032384571574 - Sensititre | 2025-04-21 |
| 05032384571758 - Sensititre | 2025-04-21 |
| 05032384580132 - Sensititre | 2025-04-21 |
| 05032384580613 - Sensititre | 2025-04-21 |
| M578GN2F2 - Sensititre | 2025-03-31 |
| M578GN3F2 - Sensititre | 2025-03-31 |
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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