AccessGUDID - DEVICE: N/A (00819398022170)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: L27
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L27
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398022170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: DTM (Dermatophyte Test Media) Agar Slant, 7.5ml Slant, order by the package of 20 (Dermatophyte Test Medium) For the isolation and identification of dermatophytic fungi such as Microsporum canis, the causative agent of ringworm. It is also designed to detect dermatophytes such as Epidermophyton and Trichophyton spp. The addition of Gentamicin and Chlortetracycline act as broad spectrum antimicrobics to inhibit a wide range of interfering gram-positive and gram-negative bacteria. Cycloheximide is added to inhibit saprophytic non-pathogenic fungi. Phenol red, the pH indicator, is affected by the presence of dermatophytes (Epidermophyton, Microsporum, and Trichophyton spp.), which all produce alkaline metabolites. Vials are made of shatter resistant polycarbonate plastic with a wide mouth opening for easy inoculatio

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?
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSI	Culture Media, Selective And Differential

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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12e0c8e4-c536-45fb-ae39-6fe2bc37d35d
Public Version Date: June 11, 2020
Public Version Number: 1
DI Record Publish Date: June 03, 2020