AccessGUDID - DEVICE: N/A (00819398028592)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Z120
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028592
Issuing Agency: GS1
Commercial Distribution End Date: July 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: C. diff PRO, a rapid proline and indole test for Clostridioides difficile, 25 test cards, 1 reagent, 16oz jar C. diff PRO™ Test Kit is recommended for use in screening suspected Clostridioides difficile isolates for L-proline aminopeptidase activity and a lack of indole activity. The test performs a proline separately from indole for a clear test interpretation. Developing Reagent (1) 00819398028585 C. diff PRO Card (25) 00819398027113

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?
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
LIB	Device, General Purpose, Microbiology, Diagnostic

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: 77e339f3-11d4-4fb2-9b4f-92bc142bc8b1
Public Version Date: July 31, 2023
Public Version Number: 3
DI Record Publish Date: August 06, 2020