AccessGUDID - DEVICE: N/A (00819398026857)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z14
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026857
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Rapid Anginosus ID Kit, to assist in the identification of Streptococcus anginosis (S. milleri), 10 tests per kit For the rapid identification of the Streptococcus anginosus group (formerly S. milleri) by the detection of arginine decarboxylase activity and production of acetoin. Results in as little as four hours. Easy color change readout, time saving kit format is cost effective. Each kit contains: 10 tubes of Rapid Arginine 10 tubes of Rapid VP

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?
43509	Voges-Proskauer (VP) microbial reagent IVD	One or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.	Active	false
51838	Multiple Vibrio species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Vibrio bacteria isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSE	Culture Media, Multiple Biochemical Test

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: 93882040-ccf3-4435-a29f-47afb03871c1
Public Version Date: June 19, 2020
Public Version Number: 1
DI Record Publish Date: June 11, 2020