AccessGUDID - DEVICE: N/A (00819398027236)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z119
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z119
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398027236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: OxiDrops, liquid oxidase reagent for spot test, 7ml, dropper bottle, by Hardy Diagnostics For testing the oxidase reaction, contains tetramethyl-p-phenylenediamine. Simply place one drop on the suspect colony (directly on the plate) and look for the color reaction. Can also be used on filter paper (cat. no. 28310048). Positives turn purple.

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?
38062	Oxidase production microbial reagent IVD	A substance or reactant, which may be impregnated on a strip or disc, intended to be used in microbial testing to detect the enzyme oxidase, produced by a microorganism isolated from a clinical specimen by culture.	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: 42b174f0-80ee-49fa-b9e4-ac748bb77df6
Public Version Date: June 18, 2020
Public Version Number: 1
DI Record Publish Date: June 10, 2020