FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST
DI: M578V4000
·
Model: V4000
·
TREK DIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST
- Primary DI
- M578V4000
- Version / Model
- V4000
- Company Name
- TREK DIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 298203498
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 3
- Public Version Date
- 2022-12-23
- Public Version Status
- Update
- Public Device Record Key
- 2b9034ef-7f11-4a81-9834-27b751e85416
- Distribution End Date
- 2022-12-21
Device Description
The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument.
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 |
|---|---|---|---|---|
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56747 | Microorganism identification/antimicrobial-susceptibility analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M578V4000 | HIBCC |
Customer Contacts
- Phone
- +441256694238
- [email protected]