AccessGUDID - DEVICE: N/A (00819398028493)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z604
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z604
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028493
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Nocardia Hydrolysis Kit for Actinomycetes, 18ml, (Total of 20 tubes) 20x125mm tubes of 4 different media types (5 each of Casein, Xanthine, Hypoxanthine, and Tyrosine Agars, in 20x125mm tubes, deep) (Nocardia Hydrolysis Kit) For use in determining the hydrolysis reaction on casein, xanthine, hypoxanthine, and tyrosine by Nocardia, Actinomycetales, Actinomadura, and Streptomyces spp. Box contains 5 tubes of each media. 20 tubes total. Contains: Casein Agar, Deep 18ml (5) 00819398022941 Xanthine Agar, Deep 18ml (5) 00819398028462 Hypoxathine Agar, Deep 18ml (5) 00819398028479 Tyrosine Agar, Deep 18ml (5) 00819398028486

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?
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
JSH	Culture Media, Non-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: 8419c63e-d647-4d6f-ad03-fcd6ed9b574f
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020