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Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V4000 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M578V4000 FDA UDI
- FDA Product Code
- LRG FDA UDI
- GMDN Term
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST by Trek Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems, Inc.
Sources (1)
- FDA UDI 2b9034ef-7f11-4a81-9834-27b751e85416 36 fields · synced May 30, 2026