AccessGUDID - DEVICE: N/A (00819398028561)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z111
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Indoxyl Acetate Disks, rapid test for Campylobacter, 25 disks tests per pack For the identification and differentiation of Campylobacter, Wolinella and Helicobacter. Look for a blue to blue-green color within only 30 minutes.

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?
58239	Chromogenic/colorimetric substrate reagent IVD	A substance or reactant that produces colour in response to a biochemical reaction and intended to be used in combination with other IVDs to test a clinical specimen, typically using an enzyme immunoassay or immunoblot method. Substrate examples include NBT, BCIP, TMB, 4CN, DAB.	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: a0751b15-42a2-4ce5-9469-543603da50c6
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: July 09, 2020