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 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 | 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
| 05032384571819 - Sensititre | 2024-03-14 |
| 05032384474509 - Sensititre™ Vizion™ | 2023-10-02Sensititre™ 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. |
| 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™ | 2023-10-02 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]
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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