AccessGUDID - DEVICE: N/A (00819398020947)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z18
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z18
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398020947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Hippurate Disks, 25 disks/jar. Hippurate disks are used for the sodium hippurate hydrolysis test. Glycine, an end product of hippurate hydrolysis, reacts with ninhydrin to produce a purple color. Hippurate is commonly used to presumptively identify Gardnerella vaginalis, Listeria monocytogenes, Campylobacter jejuni and group B streptococci.

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?
43702	Hippurate hydrolase microbial reagent IVD	A substance or reactant intended to be used in microbial testing to detect the enzyme hippurate hydrolase, 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: 6853e0ce-dd3e-4fff-bad7-2fc057e8e5bd
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022