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Sensititre Yeastone Susceptibility Plates

FDA UDI

Class II (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES FDA UDI
Generic Name
Multiple-type pathogen antimicrobial susceptibility testing kit IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
YO10 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00848838036835 FDA UDI
FDA Product Code
NGZ FDA UDI
JWY FDA UDI
LRG FDA UDI
LTT FDA UDI
GMDN Term
Multiple-type pathogen antimicrobial susceptibility testing kit 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-type pathogen antimicrobial susceptibility testing kit IVD

Sensititre Yeastone Susceptibility Plates by Remel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type pathogen antimicrobial susceptibility testing kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI bb007a6b-9f9c-487f-aca7-989f27fafe9f 33 fields · synced May 30, 2026