AccessGUDID - DEVICE: eSensor® XT-8 (00857167005238)

GUDID

Device Identifier (DI) Information

Brand Name: eSensor® XT-8
Version or Model: eSensor® Thrombophilia Risk Test Reagent Test (TRT)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MT004008
Company Name: GENMARK DIAGNOSTICS, INC.

Primary DI Number: 00857167005238
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® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)

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?
56151	Multiple thrombophilia marker IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thrombophilia markers in a clinical specimen, using a clotting method. Analytes detected may include protein C, protein S, factor V Leiden and/or their activated components, either alone or in combination.	Active	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: b9de1c89-0888-4e0c-b292-e04b15ebbc12
Public Version Date: August 15, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2016