AccessGUDID - DEVICE: Alethia™ Group A Streptococcus (00840733102264)

GUDID

Device Identifier (DI) Information

Brand Name: Alethia™ Group A Streptococcus
Version or Model: 480150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 480150
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733102264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.

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?
51714	Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT).	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 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ec8b297-a956-42d9-a208-8ebebcb508f6
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 09, 2019