AccessGUDID - DEVICE: HardyCHROM (00816576025794)

GUDID

Device Identifier (DI) Information

Brand Name: HardyCHROM
Version or Model: G327
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G327
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576025794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: HardyCHROM™ SS NoPro Agar, 15x100mm Plate, 21mL. Hardy Diagnostics HardyCHROM™ SS NoPro (no-Proteus) Agar is recommended for the selective isolation and differentiation of Salmonella and Shigella spp. from stool. HardyCHROM™ SS NoPro Agar is intended as a primary screening tool to distinguish Salmonella and Shigella spp. from non-pathogenic enteric bacteria based on colony color, while inhibiting the growth and characteristic swarming of Proteus spp. The enhanced inhibition of Proteus reduces the expense involved in working up non-pathogens that could mimic enteric pathogens. Further species confirmation of suspect colonies via conventional or automated methods is recommended.

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: 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: 9abacde3-a0e3-4805-a2fe-2030b324dfb6
Public Version Date: May 28, 2020
Public Version Number: 1
DI Record Publish Date: May 20, 2020