AccessGUDID - DEVICE: eSensor® XT-8 (00857167005092)

GUDID

Device Identifier (DI) Information

Brand Name: eSensor® XT-8
Version or Model: eSensor® Respiratory Viral Panel (RVP)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KT021620
Company Name: GENMARK DIAGNOSTICS, INC.

Primary DI Number: 00857167005092
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 962104217 *Terms of Use

Device Description: eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)

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?
48245	Multiple-genus respiratory virus antigen IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea308c1f-e1b3-4ae5-891f-568fab233344
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016