AccessGUDID - DEVICE: Trinity Biotech (05391516748711)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 40-5020M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-5020M
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516748711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM antibody to T. pallidum, 20 Tests

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):	No
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?
51810	Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWL	Antigen, Treponema Pallidum For Fta-Abs Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae8caee8-adb3-4ed2-aadb-224fc592a03a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 18, 2016