DEVICE: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (00848838036835)
Device Identifier (DI) Information
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
YO10
In Commercial Distribution
REMEL, INC.
YO10
In Commercial Distribution
REMEL, INC.
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
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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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 [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
bb007a6b-9f9c-487f-aca7-989f27fafe9f
June 28, 2023
1
June 20, 2023
June 28, 2023
1
June 20, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined