AccessGUDID - DEVICE: N/A (00816576028245)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z112
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576028245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Lysostaphin, differentiates between Micrococcus and Staphylococcus, HardyDisk™, 50 disks per cartridge Used to rapidly differentiate Staphylococcus spp. and Micrococcus spp. based on lysostaphin resistance. Make a suspension of the bacteria, add the disk, look for a clearing of turbidity if Staph is present.

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?
50420	Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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: 8fac6b6b-59d8-4d4b-8aae-3d93511ce576
Public Version Date: July 17, 2020
Public Version Number: 1
DI Record Publish Date: July 09, 2020