AccessGUDID - DEVICE: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (00848838036835)

GUDID

Device Identifier (DI) Information

Brand Name: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
Version or Model: YO10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838036835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: The Sensititre® YeastOne® Susceptibility system is a micro-version of the broth dilution susceptibility test. Various antifungal agents are serially diluted to concentrations bridging the range of the clinical interest in autoclaved diluent, which contains a colorimetric growth indicating compound. Each micro-dilution plate is individually packaged in foil. After inoculation, plates are sealed with an adhesive seal, incubated at 35°C for 24 hours and examined for growth.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
63870	Multiple-type pathogen antimicrobial susceptibility testing kit IVD	A collection of reagents and other associated materials containing a range of antimicrobial agents e.g., (antibacterial/antibiotic, antifungal/antimycotic and/or antimycobacterial) that may be impregnated on individual testing discs, in a strip format or a microplate, intended to be used to determine the susceptibility profile of a specific pathogen (bacterium, fungus and/or Mycobacterium), in a clinical specimen and/or culture isolate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGZ	Susceptibility Test Plate, Antifungal
JWY	Manual Antimicrobial Susceptibility Test Systems
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTT	Panels, Test, Susceptibility, Antimicrobial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: bb007a6b-9f9c-487f-aca7-989f27fafe9f
Public Version Date: June 28, 2023
Public Version Number: 1
DI Record Publish Date: June 20, 2023