AccessGUDID - DEVICE: N/A (00819398027427)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z73
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z73
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398027427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Nitrate Reagent C, Zinc Dust, 5gm For the completion of the nitrate reduction test. Confirms negatives after adding Nitrate A, product number Z124 or Z71; and Nitrate B, product number Z125 or Z72 reagents. True negatives will turn red after the zinc dust is added.

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?
35841	Nitrate reduction microbial reagent IVD	One or multiple substances or reactants intended to be used in microbial testing to detect nitratase enzyme production, by demonstrating the reduction of nitrate through a visible colour change in an organism 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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a36717d0-0445-4d96-b16d-46b5222d7121
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020