AccessGUDID - DEVICE: Revogene® GBS LB (00628055344117)

GUDID

Device Identifier (DI) Information

Brand Name: Revogene® GBS LB
Version or Model: 410200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 410200
Company Name: Meridian Bioscience Canada Inc

Primary DI Number: 00628055344117
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 204006360 *Terms of Use

Device Description: The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

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?
51753	Beta-haemolytic Group B 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 B 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
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fd3d4a7-1099-4d73-994e-d7f56ff62e6c
Public Version Date: November 08, 2021
Public Version Number: 3
DI Record Publish Date: October 21, 2019