Sensititre™ OptiRead™
GUDID 05032384474530
The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The reading is initiated via the Sensititre SWIN software and the data from the Sensititre™ OptiRead™ are then transferred back to the SWIN software where the results are generated. The device is for professional use only and is not intended for self-testing.
TREK DIAGNOSTIC SYSTEMS LIMITED
Microorganism identification/antimicrobial-susceptibility analyser IVD| Primary Device ID | 05032384474530 |
| NIH Device Record Key | 7d301da6-ec34-4404-87c5-4506b2bb9bc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sensititre™ OptiRead™ |
| Version Model Number | V3030 |
| 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 | 05032384474530 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110583
FDA Product Code
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
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
| 05032384571673 - Sensititre | 2024-08-02 |
| 05032384571680 - Sensititre | 2024-08-02 |
| 05032384571659 - Sensititre | 2024-08-02 |
| 05032384503513 - Sensititre | 2024-08-02 |
| 05032384474561 - Sensititre | 2024-08-02 |
| 05032384571505 - Sensititre | 2024-08-01 |
| 05032384571772 - Sensititre | 2024-08-01 |
| 05032384571802 - Sensititre | 2024-08-01 |
Trademark Results [Sensititre]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSITITRE 73161811 1126962 Dead/Cancelled |
UAC INTERNATIONAL LIMITED 1978-03-13 |
 SENSITITRE 73099700 1113936 Live/Registered |
UAC INTERNATIONAL LIMITED 1976-09-13 |
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