Sensititire® OptiRead™

GUDID 00848838074530

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™.

REMEL, INC.

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 00848838074530
• NIH Device Record Key: 91f2cff5-c94a-4930-982b-f47841861185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensititire® OptiRead™
• Version Model Number: V3030
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838074530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110583

FDA Product Code

• LRG: Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by REMEL, INC.

• 00848838058455 - Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM): 2024-11-21
• 00848838003240 - REMEL: 2024-11-07 Tergitol 7 Agar w/TTC 10/PK
• 00848838007736 - REMEL: 2024-11-07 Lysozyme Broth (5ml) 20/PK
• 00842558116419 - ACT I Transport PK/10: 2024-08-14
• 00842558116426 - ACT II Transport PK/10: 2024-08-14
• 00842558116433 - ACT II Dual Transport PK/10: 2024-08-14
• 05032384519903 - ProSpecT: 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST
• 00848838002724 - REMEL: 2024-05-14 Pseudomonas P Agar 10/PK