Identity
- Trade Name
- Sensititire® OptiRead™ FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for non-fastidious and fastidious Gram positive cocci and non fastidious Gram negative organisms, through the use of dedicated Sensititre® SWIN software. MIC and BP Susceptibility plates can either be read manually or automatically on the Sensititre OptiRead™, Autoreader® or the ARIS® in combination with theAutoreader® or OptiRead™. FDA UDI
- Model / Reference
- V3030 FDA UDI
- Description
- The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for non-fastidious and fastidious Gram positive cocci and non fastidious Gram negative organisms, through the use of dedicated Sensititre® SWIN software. MIC and BP Susceptibility plates can either be read manually or automatically on the Sensititre OptiRead™, Autoreader® or the ARIS® in combination with theAutoreader® or OptiRead™. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838074530 FDA UDI
- FDA Product Code
- LRG FDA UDIJWY 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
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microorganism identification/antimicrobial-susceptibility analyser IVD
Sensititire® OptiRead™ by Remel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microorganism identification/antimicrobial-susceptibility analyser IVD.
- VITEK® 2 COMPACT — BIOMERIEUX , INC. · Class II
- MicroScan — Beckman Coulter, Inc. · Class I
- MicroScan — Beckman Coulter, Inc. · Class II
- VITEK®2 Compact — BIOMERIEUX , INC. · Class II
- VITEK®2 — BIOMERIEUX , INC. · Class II
- VITEK®2 — BIOMERIEUX , INC. · Class II
- BD Phoenix™ M50 Automated Microbiology System — BECTON DICKINSON AND COMPANY · Class II
- VITEK® 2 COMPACT — BIOMERIEUX , INC. · Class II
Cleared under the same submission
K111429 also covers:
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
- Sensititre — Trek Diagnostic Systems, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 91f2cff5-c94a-4930-982b-f47841861185 34 fields · synced Jun 1, 2026