AccessGUDID - DEVICE: N/A (00819398026437)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z205
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Rapid Trehalose Broth, 0.35ml, for Candida glabrata, optically clear, shatter resistant, polycarbonate tube, 20 tests per package Carbon Assimilation Test. For the identification of yeasts, especially Candida (Torulopsis) glabrata.

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:	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?
36016	Trehalose utilization microbial reagent IVD	A substance or reactant intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to ferment the carbohydrate trehalose.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSF	Culture Media, Single Biochemical Test

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: 7605ac38-f5e8-435d-8bb7-eb95f3cc8475
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020