AccessGUDID - DEVICE: GlabrataQuick™ (00819398028691)

GUDID

Device Identifier (DI) Information

Brand Name: GlabrataQuick™
Version or Model: Z298
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z298
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: GlabrataQuick™, for the identification of Candida glabrata, 24 tests GlabrataQuick™, contains two 96 well trays and 24 Inoculation Buffer tubes with 1ml fill to complete a total of 24 tests. GlabrataQuick™ will accurately identify Candida glabrata within one to two hours. It tests for three carbohydrates for greater accuracy; trehalose, sucrose, and maltose. Easy and distinct color read-out. Carbohydrates turn from blue to yellow. A great test to use in conjunction with the HardyCHROM Candida plate (cat. no. G301). Contains: GlabrataQuick Reaction Strips (24) 00819398027595 GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684

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):	No
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?
52069	Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the yeast species Candida albicans and/or Candida glabrata in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	Device, General Purpose, Microbiology, Diagnostic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f94cc80-66c7-4fbb-af95-55d33ce26686
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020