FDA UDI
In Commercial Distribution
🇺🇸 United States
Sensititre AIM™
DI: 05032384497409
·
Model: V3020
·
TREK DIAGNOSTIC SYSTEMS LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sensititre AIM™
- Primary DI
- 05032384497409
- Version / Model
- V3020
- Company Name
- TREK DIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 298203498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-22
- Public Version
- 1
- Public Version Date
- 2023-10-02
- Public Version Status
- New
- Public Device Record Key
- 6249dd0d-6772-49e2-aaa8-894649a9bafc
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIE | Reagent/Device, Inoculum Calibration | Microbiology | 866.1640 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Microbiology | 866.1640 | 2 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56737 | Antimicrobial susceptibility analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05032384497409 | GS1 |
Customer Contacts
- Phone
- +441256694238
- [email protected]