AccessGUDID - DEVICE: illumigene Group A Streptococcus External Control Kit (00840733101328)

GUDID

Device Identifier (DI) Information

Brand Name: illumigene Group A Streptococcus External Control Kit
Version or Model: 279910
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 279910
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101328
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.

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):	Yes
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?
51716	Beta-haemolytic Group A Streptococcus nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System
OYZ	Group A Streptococcus Nucleic Acid Amplification Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122019	000

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5010624b-d0c5-466e-a9a1-a0ccd09bf11b
Public Version Date: July 16, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016