Sensititre™ Vizion™
GUDID 05032384474509
Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWIN software, so that the results are displayed at the SWIN PC and can be read by the user. The Sensititre™ Vizion™ is intended for use with the Sensititre™ MIC or BP Susceptibility Test System. The Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre™ Vizion™ is an alternate manual reading method for the Sensititre™ MIC plates, and for non-fastidious Gram-positive, Gram-negative, and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.
TREK DIAGNOSTIC SYSTEMS LIMITED
Antimicrobial susceptibility analyser IVD| Primary Device ID | 05032384474509 |
| NIH Device Record Key | 80175b61-731a-4541-893c-10d601e19073 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sensititre™ Vizion™ |
| Version Model Number | V2021 |
| 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 | 05032384474509 [Primary] |
FDA Product Code
| JWY | Manual Antimicrobial Susceptibility Test 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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