AccessGUDID - DEVICE: Sensititire® OptiRead™ (00848838074530)

GUDID

Device Identifier (DI) Information

Brand Name: Sensititire® OptiRead™
Version or Model: V3030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838074530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device 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™.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110583	000
K111429	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91f2cff5-c94a-4930-982b-f47841861185
Public Version Date: June 28, 2023
Public Version Number: 1
DI Record Publish Date: June 20, 2023