AccessGUDID - DEVICE: Trinity Biotech (05391516748841)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: B1029-70B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B1029-70B
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516748841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: Toxi-Titer Diluent, 50 mL

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Clostridium difficile antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen.

FDA Product Code

[?]

Product Code	Product Code Name
MCB	Antigen, C. Difficile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833447	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
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: e1665c04-2832-42a3-91b7-d67bf98b7b36
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016