AccessGUDID - DEVICE: N/A (00819398027465)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z65
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z65
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398027465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Indole, DMACA Spot, for indole spot test on filter paper, cinnamaldehyde, 15ml dropper vial To perform a rapid spot indole test on filter paper (cat. no. 28310048). 15ml dropper bottle. Not for the tube indole test, see Kovac's Indole, Z67.

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?
43720	Indole/Kovac's microbial reagent IVD	A substance or reactant, sometimes referred to as indole reagent or Kovac's reagent, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.	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: No 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: 606bc553-e85a-4339-9aee-f222835dbf31
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020