AccessGUDID - DEVICE: Trinity Biotech (05391516741873)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 450-1-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 450-1-50
Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY

Primary DI Number: 05391516741873
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 988298840 *Terms of Use

Device Description: Bile Acids Reagent A (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:	No
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58127	Total bile acid 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 quantitative measurement of total bile acids in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWW	Radioimmunoassay, Cholyglycine, Bile Acids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K872296	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
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: abb6d403-dac6-47ee-9cd3-ee750f221d99
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016