AccessGUDID - DEVICE: HardyCHROM™ (00816576020140)

GUDID

Device Identifier (DI) Information

Brand Name: HardyCHROM™
Version or Model: G307
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G307
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: HardyCHROM™ MRSA A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE.

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):	Yes
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?
58637	MRSA agar culture medium IVD, chromogenic	A selective and/or differential agar culture medium containing chromogenic substrates intended to be used to screen for the presence of methicillin-resistant Staphylococcus aureus (MRSA) microorganisms in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102922	000

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec9a9c39-8716-4cb3-9db8-7ee6444b79de
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016